An interventional study of Cardio-Metabolic Clinic in Cardiovascular Disease, Cardiometabolic Diseases and Diabetes Type 2, sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to investigate the effects of a specialized Cardio-Metabolic Clinic (CMC) in people with type 2 diabetes and established cardiovascular disease. The CMC provides integrated and individualized diabetes and cardiovascular care aimed at optimizing medication, lifestyle, and management of related health conditions. Treatment recommendations are supported by a decision-support algorithm combining individual patient information with current clinical guidelines.
Echo-CT-ProtecT-2D comprises two parallel studies conducted within the same randomized study population:
Study 1 - EchoProtecT-2D focuses on cardiac function and heart failure phenotyping. The main questions are:
Study 2 - CT-ProtecT-2D focuses on coronary inflammation and atherosclerosis. The main questions are:
Participants will be randomly assigned to either treatment in the CMC or usual care provided by their regular healthcare providers.
Participants will:
BACKGROUND AND RATIONALE Type 2 diabetes mellitus (T2D) is a major and growing global health challenge, affecting an estimated 11.1% of the adult population worldwide. Despite substantial advances in treatment, cardiovascular disease (CVD) remains a leading cause of morbidity and mortality among people with T2D.
T2D is associated with chronic low-grade inflammation and multiple metabolic and vascular abnormalities that contribute to cardiovascular complications and myocardial remodeling. Consequently, people with T2D are at increased risk of developing both at atherosclerotic disease and heart failure, particularly heart failure with preserved ejection fraction (HFpEF).
HFpEF remains particularly challenging to diagnose, and previous studies have suggested a considerable burden of previously unrecognized HFpEF among people with T2D.
Recent major therapeutic advances including Sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide-1 receptor agonists (GLP1-RA) and non-steroidal mineralocorticoid receptor antagonists have transformed the prevention of cardiac and vascular complications, with proven benefits in HFpEF, cardiovascular outcomes and diabetic kidney disease.
Beyond cardiovascular protection, these therapies may also improve systemic inflammation, plaque volume in coronary arteries and cardiac function.
However, despite increasing theurapeutic options, the implementation of evidence-based therapies in clinical practice remains suboptimal. Current care models are often fragmented, with cardiology, endocrinology, nephrology, and primary care operating independently. This may lead to delayed treatment optimization, inconsistent implementation of guidelines and increased patient inconvenience and healthcare costs. More importantly, multimorbid patients, such as those with combined CVD and T2D, may be particularly vulnerable to these limitations.
The Cardio-Metabolic Clinic (CMC) was developed to address this implementation gap by combining comprehensive clinical assessment, structured guideline-based decision support, and access to multidisciplinary specialist expertise within an integrated care model.
Echo-CT-ProtecT-2D evaluates the cardiovascular effects of this approach through two parallel and independently evaluated studies conducted within the same randomized study population:
EchoProtecT-2D - Cardiac Function and Heart Failure Phenotyping Study, focusing on cardiac function, exercise hemodynamics, and heart failure phenotyping; and CT-ProtecT-2D - Coronary Inflammation and Atherosclerosis Study, focusing on coronary inflammation and atherosclerotic plaque characteristics.
HYPOTHESES
EchoProtecT-2D - Cardiac Function and Heart Failure Phenotyping Study
Primary Hypothesis - Left Ventricular Hemodynamics We hypothesize that optimized implementation of evidence-based multifactorial cardiometabolic treatment leads to greater improvement in left ventricular function compared with usual care, reflected primarily by a greater reduction in left ventricular filling pressure, assessed by resting E/e', from baseline to 12 months. We further hypothesize that the treatment effect may be greater among participants with HFpEF.
Heart Failure Phenotyping We hypothesize that a substantial proportion of participants with T2D and established cardiovascular disease have previously unrecognized heart failure, with HFpEF being the predominant phenotype.
Systemic Inflammation We hypothesize that optimized implementation of evidence-based multifactorial cardiometabolic treatment reduces systemic inflammation more effectively than usual care, reflected by greater reductions in IL-6 and other circulating inflammatory biomarkers.
Functional Capacity and Patient-Reported Outcomes We hypothesize that optimized implementation of evidence-based multifactorial cardiometabolic treatment improves functional exercise capacity, symptom burden, and health-related quality of life compared with usual care.
CT-ProtecT-2D - Coronary Inflammation and Atherosclerosis Study
Primary Hypothesis - Coronary Inflammation We hypothesize that optimized implementation of evidence-based multifactorial cardiometabolic treatment reduces coronary inflammation compared with usual care, reflected primarily by a greater reduction in global mean pericoronary adipose tissue (PCAT) attenuation from baseline to 12 months.
Coronary Atherosclerotic Plaque Burden We hypothesize that optimized implementation of evidence-based multifactorial cardiometabolic treatment reduces coronary atherosclerotic plaque burden compared with usual care.
Coronary Plaque Composition and High-Risk Features We hypothesize that optimized implementation of evidence-based multifactorial cardiometabolic treatment results in favorable changes in coronary plaque composition and CT-derived high-risk plaque characteristics compared with usual care.
METHODS Echo-CT-ProtecT-2D is a single-center, open-label, prospective, randomized controlled trial embedded within the ongoing ProtecT-2D trial (NCT06203860). The study will be conducted at the Cardiovascular Research Unit, Odense University Hospital, Svendborg, Denmark. Echo-CT-ProtecT-2D comprises two parallel substudies, EchoProtecT-2D and CT-ProtecT-2D, focusing on echocardiographic and coronary CT angiography-based assessments, respectively (CCTA). The two substudies have distinct scientific aims and independently evaluated primary endpoints while sharing the same study population, intervention, and organizational and logistical framework.
Participants are randomized in a 2:1 ratio to either the CMC intervention or usual care. Participants allocated to usual care continue treatment through their general practitioner and/or relevant hospital outpatient clinics.
Participants undergo comprehensive cardiovascular and metabolic assessment at baseline and follow-up. The study includes echocardiographic assessment of cardiac function at rest and during exercise, Coronary CT angiography, 6 minute walk testing to asses functional capacity, inflammatory biomarkers, patient reported symptoms, and questionnaire-assessment of health-related quality of life (QoL). Detailed cardiac phenotyping will additionally be used to explore the prevalence of previously unrecognized heart failure, particularly HFpEF.
INTERVENTION - The Cardio-metabolic Clinic (CMC) :
The CMC provides integrated, individualized, and multifactorial management of T2D and cardiovascular disease. A central component of the intervention is a REDCap-integrated clinical decision-support algorithm developed according to current clinical guidelines for T2D and CVD.
Individual patient characteristics, current treatment, comorbidities, and cardiovascular risk factors are entered into the system. Based on these data, the algorithm provides structured guideline-based treatment recommendations across ten prespecified clinical domains: dyslipidemia, hypertension, thrombosis prophylaxis, diabetes management, assessment of microvascular complications, consideration of SGLT2 inhibitors and/or GLP-1 receptor agonists, lifestyle modification, peripheral artery disease, HFpEF, and vaccinations.
The algorithm supports systematic identification of relevant treatment opportunities and facilitate implementation of evidence-based therapies while maintaining individualized clinical decision-making.
ORGANIZATION IN THE CMC:
The Cardio-metabolic Clinic is an integrated care model designed to be a resource-efficient scalable approach to improving implementation of evidence-based cardiometabolic treatment and is structured in three interconnected layers.
Frontline consultations are conducted by trained medical staff, either medical students or a resident doctor, who perform standardized clinical assessments and enter data into a REDCap-based electronic form with the abovementioned integrated decision-support algorithm.
Based on individual patient data the algorithm generates structured, guideline-based treatment recommendations to support systematic implementation of all therapies relevant to the patient in question.
The next layer consists of a supervising cardiologist to ensure clinical accuracy. When needed, complex issues can be discussed with a third layer, consisting of relevant specialists in endocrinology, nephrology and hepatology, ensuring access to multidisciplinary expertise when required.
This structure aims to combine standardized implementation of guideline-directed treatment with individualized multidisciplinary specialist care integrated within a single clinical setting.
HEART FAILURE PHENOTYPING:
EchoProtecT-2D will characterize the burden of previously unrecognized heart failure among participants without a prior heart failure diagnosis. Comprehensive echocardiographic assessment at rest and during exercise, together with clinical and functional assessments, will be used to examine hemodynamic changes and characterize heart failure stages and phenotypes, with particular emphasis on HFpEF.
LONG-TERM FOLLOW-UP All participants are scheduled for a 3-year follow-up visit as part of the parent ProtecT-2D trial. Therefore the EchoProtecT-2D may be extended to include repeat echocardiographic assessment at the 3-year follow-up.
If implemented, the long-term echocardiographic follow-up, corresponding outcomes, and statistical analyses will be prespecified in an updated study protocol and Statistical Analysis Plan prior to initiation of the 3-year echocardiographic assessments.
STATISTICAL ANALYSES The parallel studies; EchoProtecT-2D and CT-ProtecT-2D, address seperate scientific hypotheses and are evaluated independently within the overall Echo-CT-ProtecT-2D framework. Each study has a separate prespecified primary hypothesis, primary endpoint, and sample size calculation.
EchoProtecT-2D - Cardiac Function and Heart Failure Phenotyping Study Sample size estimation is based on the primary echocardiographic endpoint, E/e'. To detect a clinically relevant between-group difference of 15% in E/e' with 80% statistical power, a two-sided significance level of 0.05, and a 2:1 allocation ratio, a minimum of 111 evaluable participants is required.
Allowing for 10-15% of participants being non-evaluable due to dropout and/or insufficient echocardiographic image quality, and assuming an HFpEF prevalence of approximately 35%, approximately 375 participants will be included, thereby ensuring a sufficient number of evaluable participants for the prespecified HFpEF analysis.
The primary endpoint is the between-group difference in change in resting E/e' from baseline to 12 months.
CT-ProtecT-2D - Coronary Inflammation and Atherosclerosis Study
Sample size estimation is based on the primary CT-derived endpoint, global mean pericoronary adipose tissue (PCAT) attenuation. To detect a clinically relevant between-group difference of 7% in global mean PCAT attenuation with 90% statistical power, a two-sided significance level of 0.05, and a 2:1 allocation ratio, a total of 141 evaluable participants is required.
The primary endpoint is the between-group difference in change in global mean PCAT attenuation from baseline to 12 months.
Further Statistical Considerations The two primary hypotheses will be analyzed and interpreted independently, and conclusions regarding one study will not depend on the results of the other.
Secondary outcomes encompass both key secondary outcomes addressing the principal prespecified hypotheses and exploratory secondary outcomes providing additional mechanistic and phenotypic characterization.
Detailed statistical methods, including the hierarchy and statistical treatment of secondary outcomes, model specification, handling of missing data, multiplicity within each study, subgroup and interaction analyses, and sensitivity analyses, will be prespecified in a Statistical Analysis Plan (SAP) finalized prior to outcome analyses.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 375 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Odense University Hospital is the lead sponsor of 477 studies on the registry; 109 are open to participants now.
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4a. Atherosclerotic disease defined as one of the following: I. Prior acute coronary syndrome, defined according to ESC guidelines.
II. Chronic coronary syndrome defined according to ESC guidelines:
a) Angina pectoris AND b) Signs of coronary atherosclerosis assessed with either coronary CT angiography (CTA) or myocardial-scintigraphy (MPI) or coronary angiography (CAG) AND c) treatment with statins and/or acetylsalicylic acid.
III. Ischemic heart disease defined by one of the following criteria: a) Myocardial-scintigraphy: >10% reversibility OR b) Coronary CT angiography: Coronary Artery Calcium-score >100.
IV. Non coronary vascular disease defined as:
Peripheral arterial disease (PAD) PAD is defined as: Claudication intermittence AND pathological ankle brachial index (ABI) AND/OR vascular PAD surgery AND/OR ischemic amputation 4b. Atrial fibrillation and/or flutter, including paroxysmal, persistent and chronic disease defined according to ESC guidelines.
4c. Clinically significant valvular heart disease (which requires control in outpatient clinic of cardiology), such as: Aortic valve stenosis, mitral valve insufficiency, and patients with aortic dilatation.
4d. Hypertension treated with a minimum of three antihypertensive drugs. 4e. Heart failure with preserved ejection fraction (HFpEF)
Exclusion Criteria:
Multifactorial management of T2D and CVD and individualized treatment optimization according to current clinical guidelines and recommendations.
Other: Cardio-Metabolic Clinic
Patients in the control group will continue to receive usual care from their general practitioner and any hospital departments or outpatient clinics involved in their ongoing care.
Multifactorial management of T2D and cardiovascular disease, including comprehensive assessment of macro- and microvascular complications and individualized treatment optimization according to current clinical guidelines and recommendations. Treatment optimization is supported by an algorithm integrating individual patient data with guideline-based recommendations. The assessment will encompass the following treatment areas: * Lipid management * Blood pressure management * Antithrombotic therapy * Glycemic targets * Prevention of diabetes-related complications * Treatment of vascular disease affecting the lower extremities * Evaluation of cardioprotective drugs * Counseling on lifestyle factors, including diet, smoking, alcohol, and exercise * Guidance on vaccinations
Change in resting E/e' from baseline to 12 months follow-up, comparing the intervention and usual-care groups, with dedicated analysis of the HFpEF subgroup.
E/e' is an echocardiographic measure used to estimate left ventricular filling pressure. E/e' will be calculated as the ratio of early transmitral inflow velocity (E) to early diastolic mitral annular velocity (e'), using the average of septal and lateral e' velocities.
Time frame: Baseline and 12 months
Change in global mean pericoronary adipose tissue (PCAT) attenuation from baseline to 12 months compared between the intervention and usual-care groups.
Coronary inflammation will be assessed by coronary computed tomography angiography (CCTA) using global mean pericoronary adipose tissue (PCAT) attenuation, expressed in Hounsfield units (HU). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in E/e' during exercise from baseline to 12 months comparing the intervention and usual-care groups, with dedicated analysis of the HFpEF subgroup.
E/e' during exercise will be assessed by exercise stress echocardiography as an estimate of left ventricular filling pressure. E/e' will be calculated as the ratio of early transmitral inflow velocity (E) to early diastolic mitral annular velocity (e'), using the average of septal and lateral e' velocities. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in left ventricular global longitudinal strain at rest from baseline to 12 months between the intervention and usual-care groups
Left ventricular global longitudinal strain (LV GLS) will be assessed at rest using speckle-tracking echocardiography and expressed as a percentage (%). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in left ventricular global longitudinal strain during exercise from baseline to 12 months between the intervention and usual-care groups
Left ventricular global longitudinal strain (LV GLS) will be assessed during exercise using speckle-tracking echocardiography and expressed as a percentage (%). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in left atrial volume index from baseline to 12 months comparing the intervention and usual-care groups
Left atrial volume index (LAVI) will be assessed by transthoracic echocardiography at rest and expressed in mL/m² as a measure of left atrial remodeling. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in tricuspid regurgitation peak velocity during exercise from baseline to 12 months between the intervention and usual-care groups
Tricuspid regurgitation peak velocity (TR Vmax) will be assessed during exercise stress echocardiography and expressed in m/s. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline to 12 months
Change in cardiac output reserve during exercise from baseline to 12 months compared between the intervention and usual-care groups.
Cardiac output reserve will be assessed as the increase in cardiac output from rest to exercise and expressed in L/min. Cardiac output will be derived from heart rate and stroke volume measured at rest and during exercise. Changes in cardiac output reserve from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in chronotropic response during exercise from baseline to 12 months between the intervention and usual-care groups
Chronotropic response will be assessed from the heart rate response to exercise according to prespecified criteria. The specific definition of chronotropic response and chronotropic incompetence will be prespecified in the Statistical Analysis Plan. Changes in chronotropic response from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in stroke volume augmentation during exercise from baseline to 12 months between the intervention and usual-care groups
Stroke volume augmentation will be assessed as the increase in stroke volume from rest to exercise and expressed in mL/beat. Changes in stroke volume augmentation from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in resting systolic pulmonary artery pressure from baseline to 12 months between the intervention and usual-care groups
Systolic pulmonary artery pressure (sPAP) will be estimated by transthoracic echocardiography at rest and expressed in mmHg. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in resting E/A ratio from baseline to 12 months between the intervention and usual-care groups
The ratio of early (E) to late (A) transmitral inflow velocity will be assessed by Doppler echocardiography at rest and expressed as the E/A ratio. Changes from baseline to 12 months will be compared between the intervention and usual-care groups
Time frame: Baseline and 12 months
Change in early diastolic mitral annular velocity (e') at rest from baseline to 12 months between the intervention and usual-care groups
Early diastolic mitral annular velocity (e') will be assessed by tissue Doppler echocardiography at the septal and lateral mitral annulus and expressed in cm/s. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in left ventricular ejection fraction from baseline to 12 months between the intervention and usual-care groups
Left ventricular ejection fraction (LVEF) will be assessed by transthoracic echocardiography at rest and expressed as a percentage (%). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in left ventricular mass index from baseline to 12 months between the intervention and usual-care groups
Left ventricular mass index (LVMI) will be assessed by transthoracic echocardiography, indexed to body surface area, and expressed in g/m². Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in left atrial strain from baseline to 12 months between the intervention and usual-care groups
Left atrial strain will be assessed at rest using speckle-tracking echocardiography and expressed as a percentage (%). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Prevalence of previously unrecognized HFpEF at baseline
The prevalence of previously unrecognized heart failure with preserved ejection fraction (HFpEF) will be assessed among participants without a prior diagnosis of heart failure using the following prespecified diagnostic approaches: * HFpEF defined according to European Society of Cardiology (ESC) 2026 guideline criteria, % * HFpEF according to the HFA-PEFF-diagnostic algorithm, % * HFpEF according to the H₂FPEF-score, % * HFpEF according to prespecified clinical-trial-based diagnostic frameworks, including criteria derived from the DELIVER trial, % HFpEF prevalence will be expressed as the proportion (%) of participants meeting the prespecified criteria. Concordance and differences in HFpEF classification between the diagnostic approaches will additionally be explored.
Time frame: Baseline and 12 months
Change in HFpEF classification from baseline to 12 months between the intervention and usual-care groups
HFpEF classification will be assessed according to prespecified diagnostic criteria at baseline and 12 months. Changes in classification, including transitions between HFpEF and non-HFpEF status, will be evaluated. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Prevalence of pre-heart failure and previously unrecognized HFrEF at baseline
The prevalence of pre-heart failure (Stage B) and heart failure with reduced ejection fraction (HFrEF) will be assessed at baseline according to prespecified European Society of Cardiology (ESC) 2026 guideline criteria. Prevalence will be reported separately for pre-heart failure and HFrEF.
Time frame: Baseline
Change in pre-heart failure and HFrEF classification from baseline to follow-up between the intervention and usual-care groups.
Changes in classification of pre-heart failure (Stage B) and heart failure with reduced ejection fraction (HFrEF) will be assessed from baseline to 12 and 36 months according to prespecified ESC guideline criteria. Transitions between heart failure categories over time will be assessed, and differences between the intervention and usual-care groups will be explored.
Time frame: Baseline and 12 months
Change in circulating interleukin-6 from baseline to 12 months between the intervention and usual-care groups
Circulating interleukin-6 (IL-6) concentrations will be measured at baseline and 12 months. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in high-sensitivity C-reactive protein from baseline to 12 months between the intervention and usual-care groups
Systemic inflammation will be assessed by circulating high-sensitivity C-reactive protein (hsCRP), expressed in mg/L. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in leukocyte count from baseline to 12 months between the intervention and usual-care groups
Circulating leukocyte count will be measured as an additional marker of systemic inflammation and expressed as ×10⁹/L. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in six-minute walk distance from baseline to 12 months between the intervention and usual-care groups
Functional exercise capacity will be assessed using the six-minute walk test (6MWT). The distance walked in six minutes (6MWD) will be recorded in meters. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in KCCQ-12 Overall Summary Score from baseline to 12 months between the intervention and usual-care groups
Patient-reported health status will be assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Overall Summary Score. Scores range from 0 to 100, with higher scores indicating better health status. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in EQ-5D-5L index score from baseline to 12 months between the intervention and usual-care groups.
Health-related quality of life will be assessed using the EQ-5D-5L. The descriptive system assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Health states will be converted to an EQ-5D-5L index score using a prespecified value set. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in EQ visual analogue scale from baseline to 12 months between the intervention and usual-care groups
Self-rated health will be assessed using the EQ visual analogue scale (EQ VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
NYHA functional class at 12 months between the intervention and usual-care groups
New York Heart Association (NYHA) functional class will be assessed on an ordinal scale from Class I to Class IV, with higher classes indicating greater limitation due to symptoms. NYHA functional class at 12 months will be compared between the intervention and usual-care groups, accounting for baseline NYHA functional class.
Time frame: Baseline and 12 months
Change in vessel-specific PCAT attenuation from baseline to 12 months between the intervention and usual-care groups
Changes in vessel-specific coronary inflammation will be assessed by pericoronary adipose tissue (PCAT) attenuation measured separately around the left anterior descending artery (LAD), left circumflex artery (LCx), and right coronary artery (RCA), expressed in Hounsfield units (HU). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in lesion-specific pericoronary adipose tissue (PCAT) attenuation from baseline to 12 months between the intervention and usual-care groups
Lesion-specific coronary inflammation will be assessed by pericoronary adipose tissue (PCAT) attenuation surrounding prespecified coronary atherosclerotic lesions, measured by coronary computed tomography angiography (CCTA) and expressed in Hounsfield units (HU).
Time frame: Baseline and 12 months
Change in total coronary atheroma volume from baseline to 12 months between the intervention and usual-care groups
Total atheroma volume (TAV) will be assessed by CCTA in prespecified coronary segments and expressed in mm³. TAV will be calculated as total vessel volume minus total lumen volume. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in normalized coronary atheroma volume from baseline to 12 months between the intervention and usual-care groups
Normalized atheroma volume (NAV) will be assessed by CCTA in prespecified coronary segments. NAV will be calculated according to the prespecified normalization method described in the study protocol. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in relative coronary plaque burden assessed by percent atheroma volume from baseline to 12 months between the intervention and usual-care groups
Relative coronary plaque burden will be assessed by CCTA and quantified as percent atheroma volume (PAV), expressed as a percentage (%), in prespecified coronary segments. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in CCTA-derived coronary plaque composition from baseline to 12 months between the intervention and usual-care groups
Coronary plaque composition will be assessed by coronary computed tomography angiography (CCTA). Plaque components will be classified according to CT attenuation and quantified as plaque volume (mm³) using the following prespecified Hounsfield unit (HU) ranges: * Calcified plaque: \>351 HU * Fibrotic plaque: 131-350 HU * Fibrofatty plaque: 31-130 HU * Necrotic core plaque: -30 to 30 HU Changes in plaque component volumes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in proportion of CCTA-defined high-risk coronary plaques from baseline to 12 months between the intervention and usual-care groups
Non-calcified and mixed coronary plaques will be assessed by coronary computed tomography angiography (CCTA) for prespecified high-risk plaque characteristics, including positive remodeling, low-attenuation plaque, spotty calcification, and napkin-ring sign. A high-risk plaque will be defined as a plaque demonstrating at least two of the four prespecified high-risk plaque characteristics. The proportion of high-risk plaques will be calculated as the number of high-risk plaques divided by the total number of identified coronary plaques for each participant and expressed as a percentage (%). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Change in number of CCTA-defined high-risk coronary plaques from baseline to 12 months between the intervention and usual-care groups
Non-calcified and mixed coronary plaques will be assessed by coronary computed tomography angiography (CCTA) for prespecified high-risk plaque characteristics, including positive remodeling, low-attenuation plaque, spotty calcification, and napkin-ring sign. A high-risk plaque will be defined as a plaque demonstrating at least two of the four prespecified high-risk plaque characteristics. The number of high-risk plaques will be calculated as the number of high-risk plaques divided by the total number of identified coronary plaques for each participant and expressed as a percentage (%). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Time frame: Baseline and 12 months
Prespecified subgroup analysis on resting E/e' among participants with HFpEF at baseline
A prespecified subgroup analysis will evaluate the treatment effect on change in resting E/e' from baseline to 12 months among participants classified as having HFpEF at baseline. Effect modification according to baseline HFpEF status will additionally be assessed as prespecified in the Statistical Analysis Plan.
Time frame: Baseline and 12 months
Plan to share: Undecided — No individual participant data sharing is currently planned. However, data sharing may be considered in the future in response to scientifically relevant research proposals, provided that all applicable ethical, legal, regulatory, and data protection requirements are met and the necessary approvals and agreements are in place.
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Start is estimated for Oct 2026; primary completion for Dec 2027, 13 months later.
Of 1,032 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 13 months is below that.
Counting every sponsor, half of 1,148 studies reached it within 26 months; a quarter within 13 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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