An interventional study of Multidisciplinary Cardio-Renal Care in Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF) and Cardiovascular Diseases, sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to investigate whether care in a specialised Cardio-Renal Clinic can improve the health of people living with both cardiovascular disease and chronic kidney disease. The clinic brings together expertise in heart and kidney disease and provides structured treatment based on current clinical guidelines.
The main research questions are:
Participants will then be randomly assigned to either optimised care in the Cardio-Renal Clinic or usual care.
Participants assigned to the Cardio-Renal Clinic will have treatment reviewed and adjusted by a multidisciplinary team. The clinic may recommend or prescribe approved medications that are already used in routine care for heart and kidney disease. No experimental medications will be used.
Participants assigned to usual care will continue to receive care from a general practitioner and any hospital departments involved in treatment.
Background Cardiovascular disease (CVD) and chronic kidney disease (CKD) frequently coexist and together constitute a major global health burden associated with substantially increased morbidity, mortality, and healthcare utilisation. Importantly, the coexistence of CVD and CKD predisposes patients to heart failure with preserved ejection fraction (HFpEF), a complex clinical syndrome characterised by a high symptom burden, impaired quality of life, and a poor prognosis. HFpEF accounts for approximately half of all heart failure cases and may further aggravate the progressive interaction between cardiovascular and renal dysfunction.
Over the past decade, major therapeutic advances have improved outcomes in patients with CVD, CKD, and HFpEF. Large randomised trials, including DELIVER and EMPEROR-Preserved, have demonstrated that sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) improve clinical outcomes in patients with HFpEF. Renin-angiotensin system inhibitors and SGLT2 inhibitors also reduce adverse outcomes in patients with CKD. Furthermore, emerging evidence supports the use of non-steroidal mineralocorticoid receptor antagonists in patients with HFpEF or CKD.
Despite this strong evidence base, the implementation of guideline-directed treatment remains suboptimal. In a pilot study conducted at the study centre, only one-third of patients with coexisting CVD and CKD received fully optimised CKD treatment, consistent with findings from similar studies. Consequently, the principal challenge is no longer solely the development of effective therapies, but also the systematic implementation of existing evidence-based treatments in patients with complex multimorbidity.
Current care models are predominantly fragmented, with cardiology, nephrology, and primary care operating independently. This fragmentation leads to suboptimal coordination, delayed treatment optimisation, and inconsistent application of guidelines.
The OPTICARE Trial addresses this gap by evaluating a structured, multidisciplinary cardiorenal care model designed to optimise treatment in accordance with current clinical guidelines. The investigators hypothesise that this model will significantly improve cardiovascular and renal outcomes compared with standard care and has the potential to transform clinical pathways and future guideline recommendations.
Purpose and hypothesis The aim of this randomised trial is to evaluate the effectiveness of a systematic, specialised, multidisciplinary cardiorenal intervention, delivered through a Cardio-Renal Clinic, in improving cardiovascular and renal outcomes, reducing mortality and symptom burden, and improving quality of life and physical performance in patients with CVD and CKD.
The project consists of two studies. Study One will evaluate the short-term effects of multidisciplinary cardiorenal care after one year. Study Two will evaluate its long-term effects of the multidisciplinary cardiorenal care after five and ten years.
The investigators hypothesise that a specialised, multidisciplinary Cardio-Renal Clinic delivering guideline-directed cardiorenal care will improve cardiovascular, renal, functional, and patient-reported outcomes compared with standard care.
Methods The OPTICARE Trial is a single-centre, randomised, controlled, open-label, parallel-group trial including 500 participants with coexisting CVD and CKD.
At baseline, participants will undergo a comprehensive assessment comprising:
Clinical examinations and investigations at baseline will include:
Participants assigned to the Cardio-Renal Clinic will undergo systematic assessment and optimisation of treatment. The treatment algorithm will be based on current national and international clinical guidelines for the management of CKD, HFpEF, hypertension, dyslipidaemia, and thromboembolic risk. Additionally, participants will receive counselling on diet, physical activity, smoking cessation, alcohol consumption, weight management, and recommended vaccinations.
All treatment decisions will be based on current national and international clinical guidelines and established evidence-based practice. Treatment decisions will be supported by a decision-support algorithm integrated into REDCap. The algorithm will be updated when relevant guideline recommendations change.
Following treatment initiation or adjustment, clinical and biochemical follow-up will be arranged as clinically indicated and in accordance with current guideline recommendations.
Participants assigned to standard care will continue existing treatment without any intervention by the study team. Participants will be encouraged to continue prescribed medications and attend planned appointments with general practitioners and relevant outpatient clinics.
A comprehensive follow-up visit will be conducted one year after randomisation to evaluate the short-term effects of the intervention. The principal baseline examinations and assessments will be repeated at this visit.
After five and ten years, medical records will be reviewed to identify major cardiovascular and renal events. The five- and ten-year follow-up will contribute to the evaluation of the long-term effect of the specialised, multidisciplinary treatment provided in the Cardio-Renal Clinic.
Sample size estimation The sample size calculation is based on the long-term primary composite cardiorenal endpoint. This endpoint resembles the composite kidney and cardiovascular outcome evaluated in the DAPA-CKD trial. Among participants without diabetes in DAPA-CKD, a hazard ratio of 0.50 was reported.
Assuming a two-sided significance level of 0.05, a statistical power of 80%, and a 2:1 allocation ratio, a total of 74 primary endpoint events are required to detect the anticipated treatment effect. Assuming an annual event rate of 6% in the control group and a planned follow-up period of five years, 464 participants are estimated to provide the required number of events. To account for withdrawal and loss to follow-up, a total of 500 participants will be included.
Expected contribution This research project aims to improve the care of a high-risk patient population with treatment needs that may not be adequately addressed within existing, specialty-specific models of care. By strengthening early detection, multidisciplinary collaboration, and the implementation of guideline-directed treatment, the project has the potential to improve both short- and long-term patient outcomes.
Beyond the potential benefits to study participants, the project may contribute to the development of integrated care models within the public healthcare system. The Cardio-Renal Clinic is intended to provide a scalable and resource-efficient model that could improve continuity of care, reduce fragmentation between medical specialties, and support more individualised, evidence-based treatment pathways. If successful, the project may serve as a framework for future cardio-renal clinics in Denmark and internationally.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 500 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Compromising a multidisciplinary, structured, and specialised optimisation of cardiovascular and renal therapy, including lifestyle interventions, according to contemporary guidelines.
Other: Multidisciplinary Cardio-Renal Care
Participants will continue their current medical treatment without intervention from the study team. They will be encouraged to continue taking their prescribed medications and attend scheduled appointments with their general practitioner and relevant outpatient clinics.
A structured, multidisciplinary intervention comprising guideline-directed assessment and optimisation of cardiovascular and renal treatment, based on latest guideline recommandations from ESC and KDIGO. The intervention include treatment of: * Heart failure * Blood pressure management * Thrombosis prophylaxis * Dyslipidaemia management * Kidney protectective therapies * Treatment of kidney failure complications * Counseling on lifestyle factors, including diet, alcohol consumption, smoking, physical activity, weight management, and sleep apnea.
Long-term outcome: Major Cardiorenal Events
A composite endpoint of time to first occurrence of any of the following: * Cardiovascular and renal mortality * Worsening heart failure (heart failure hospitalisation or an urgent heart failure visit) * AMI * Stroke * End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \<15 mL/min/1.73 m² confirmed by a second measurement ≥28 days later) * A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days Measured in days.
Time frame: From baseline to 5 years of follow-up.
Short-term outcome: Diastolic function
Change in E/e' (rest) in participants with HFpEF; between-group difference. Absolute value and change from baseline.
Time frame: From baseline to 1-year follow-up
Diastolic function (rest and exercise)
Change in E/e' (rest and exercise) in the overall study population; between-group difference. Absolute value and change from baseline.
Time frame: From baseline to 1-year follow-up
Neurohormonal activation
NT-proBNP. Change from baseline to 1-year follow-up. pg/mL
Time frame: From baseline to 1-year follow-up
HFpEF classification and prevalence
Prevalence of HFpEF and comparison of diagnostic algorithms. Prevalence and change in classification from baseline to 1-year follow-up.
Time frame: From baseline to 1-year follow-up.
Albuminuria
Change in UACR from baseline to 1-year follow-up; between-group difference. mg/g
Time frame: From baseline to 1-year follow-up
eGFR slope (creatinine based)
Change in eGFR slope (total and chronic); between-group difference. mL/min/1.73 m2
Time frame: From baseline to 1-year follow-up
Cystatin C
Prognostic value of cystatin C with respect to the risk of HFpEF and its association with NYHA classification.
Time frame: Evaluated at the baseline and 1-year follow-up visit
Symptom burden (HF-related)
Change in NYHA functional class from baseline to 1-year follow-up; between-group difference.
Time frame: From baseline to 1-year follow-up.
Symptom burden (CKD-related)
Change in uremic symptom burden from baseline to 1-year follow-up; between-group difference.
Time frame: From baseline to 1-year follow-up
Physical performance
Change in 6-minute walk test from baseline to 1-year follow-up; between-group difference. In meters walked.
Time frame: From baseline to 1-year follow-up
Physical performance
Change in 1-minute sit-to-stand test from baseline to 1-year follow-up; between-group difference. Number of repetitions.
Time frame: From baseline to 1-year follow-up
Disease-specific health status
Change in KCCQ-12 score from baseline to 1-year follow-up; between-group difference
Time frame: From baseline to 1-year follow-up
Health-related quality of life
Change in EQ-5D-5L score from baseline to 1-year follow-up; between-group difference
Time frame: From baseline to 1-year follow-up
Cardiovascular risk
Change in prediction of cardiovascular events according to the established ESC scoring systems from baseline to 1-year follow-up; between-group difference.
Time frame: From baseline to 1-year follow-up.
Renal risk
Change in predicted risk of progression to end-stage kidney disease according to the Kidney Failure Risk Equation from baseline to 1-year follow-up; between-group difference.
Time frame: From baseline to 1-year follow-up.
Long-term cardiovascular outcomes (five years)
Time to first occurrence of any of the individual components: * CV mortality * HF worsening (hospitalisation or urgent outpatient visit) * AMI * Stroke Between-group difference. Measured in days.
Time frame: From baseline to 5 years of follow-up.
Long-term kidney outcomes (five years)
Time to first occurrence of any of the individual components: * Renal mortality * End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \<15 mL/min/1.73 m² confirmed by a second measurement ≥28 days later) * A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days. Measured in days.
Time frame: From baseline to 5 years of follow-up.
Composite long-term cardiorenal outcome (ten years)
A composite endpoint of time to first occurrence of any of the following: * Cardiovascular and renal mortality * Worsening heart failure (heart failure hospitalisation or an urgent heart failure visit) * AMI * Stroke * End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \<15 mL/min/1.73 m² confirmed by a second measurement ≥28 days later) * A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days. Measured in days.
Time frame: From baseline to 10 years of follow-up.
Long-term cardiovascular outcomes (ten years)
Time to first occurrence of any of the individual components: * CV mortality * HF worsening (hospitalisation or urgent outpatient visit) * AMI * Stroke Between-group difference. Measured in days.
Time frame: From baseline to 10 years of follow-up.
Long-term kidney outcomes (ten years)
Time to first occurrence of any of the individual components: * Renal mortality * End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \<15 mL/min/1.73 m² confirmed by a second measurement ≥28 days later) * A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days. Measured ind days.
Time frame: From baseline to 10 years of follow-up.
Plan to share: Yes — De-identified individual participant data underlying the results reported in peer-reviewed publications may be made available upon reasonable request after publication of the main study results.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 12 months after publication of the relevant study results and ending 5 years thereafter.
Access criteria: Access may be granted to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed and approved by the OPTICARE study team and, where required, the relevant institutional, ethical, and data-protection authorities. Approved researchers will receive access only to the de-identified data and supporting documents necessary for the approved analyses. Access will be subject to a signed data-sharing agreement and provided through a secure, approved data-transfer or analysis environment. Requests should be directed to the principal investigator.
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