An interventional study of Standard care in Chronic Heart Failure (CHF), sponsored by Novartis Pharmaceuticals. Completed at 191 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Not applicable, Interventional, and Other
This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.
In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF \< or = 40%) and NT-proBNP level > or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 1,415 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
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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.
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.
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No treatments are stipulated by this protocol - patients' HF and non-HF treatments will be observed throughout the study. The patients' treatment is entirely in the discretion of the primary care physicians
Procedure: Standard care
Patients will receive the treatment that their primary care physician has decided to prescribe for their disease
Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist)
Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type \& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.
Time frame: Baseline (Visit 1)
Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose
Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type \& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.
Time frame: Month 6
Duration of Heart Failure
The duration of Heart Failure was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Number of Patients With Current Use of Concomitant Compound
Use of concomitant compounds were collected at baseline (Visit 1)
Time frame: Baseline (Visit 1)
Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2
Use of concomitant compounds were collected at 6 months (Visit 2)
Time frame: 6 months (Visit 2)
Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics
For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters.
Time frame: 6 months
Number of Patients With Different NT-proBNP Level Categories
NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, \> 1200 pg/ml).
Time frame: One measurement in all consecutive patients at baseline (Visit 1)
Percentages of Clinically Stable Patients
Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion.
Time frame: Baseline (Visit 1)
Number of Patients by Cardiologist Prescription Practice Per Country/Region
The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline.
Time frame: 6 months
Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline
At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline.
Time frame: 10 months
Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)
Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF).
Time frame: Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)
The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure.
Time frame: Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)
Number of Patients in Different Living Conditions
Living conditions were collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Number of Patients in Different Employment Status
Employment status was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Number of Patients With Smoking Status
Smoking status was collected at baseline (visit 1).
Time frame: Baseline (Visit 1)
Number of Patients From Different Geographical Regions
Geographic regions were collected at Baseline (Visit 1).
Time frame: Baseline (visit 1)
Number of Patients With Health Insurance Status
Health insurance status was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Number of Patients at Different Educational Level
Educational level was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Number of Patients Per Primary Etiology of Heart Failure
The primary etiology of Heart Failure was collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study
HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline.
Time frame: Baseline (Visit 1), 6 months, 10 months
Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities
Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1)
Time frame: Baseline (Visit 1)
Mean Dose of Previously Taken and Current Use of Concomitant Medications
Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline
Time frame: Baseline (Visit 1), 6 months, 10 months
Number of Heart Failure (HF) Treatment Combinations
The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1).
Time frame: Baseline (Visit 1)
Duration of Treatment With Device Type
The duration of treatment with device type was collected at baseline (Visit 1)
Time frame: Baseline (Visit 1)
Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds
Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected
Time frame: Baseline (Visit 1)
Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region
For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented.
Time frame: Baseline (Visit 1)
The enrolled set consisted of 1415 patients. 861 patients were referred to a cardiologist within this study and Based on findings from the interim-analysis, Novartis decided to terminate the study prematurely in March 2018.
| Milestone | Enrolled Patients |
|---|---|
| Started | 1415 |
| Completed | 864 |
| Not completed | 551 |
| Withdrew: Patients not suitable for follow-up. | 551 |
| Milestone | Enrolled Patients |
|---|---|
| Started | 864 |
| Completed | 680 |
| Not completed | 184 |
| Withdrew: Study terminated by sponsor | 131 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Lost to follow-up | 7 |
| Withdrew: Physician decision | 6 |
| Withdrew: Adverse event | 3 |
| Withdrew: Death | 27 |
| Withdrew: Relocation | 2 |
Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type \& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.
| Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Level 1: Drug Type : Adherent | 110 | 59 |
| Level 1: Drug type : Not Adherent | 802 | 523 |
| Patients missing LVEF values | 503 | 279 |
Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type \& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.
| Percentage of Patients | Follow-Up Set |
|---|---|
| Adherence at V2, not adherent at V1 for drug type | 3.3 |
| Adherence at V2, not adherent at V1:drug type/dose | 0.8 |
| Adherence at V2 and V1 for drug type | 79.2 |
| Adherence at Visit 1 for drug type & dose | 86.7 |
The duration of Heart Failure was collected at Baseline (Visit 1).
| Participants | Enrolled Patients | Follow-Up Set |
|---|---|---|
| >3 years | 896 | 549 |
| ≤3 years | 517 | 312 |
Use of concomitant compounds were collected at baseline (Visit 1)
| Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Diuretics - without mineral corticoid antagonists | 934 | 625 |
| Beta blocking agents | 981 | 602 |
| Agents acting on the renin-angiotensin system | 834 | 491 |
| Diuretics - mineral corticoid antagonists | 664 | 416 |
| Antithrombotic agents | 401 | 256 |
| Cardiac therapy | 365 | 238 |
| Lipid modifying agents | 163 | 96 |
| Mineral supplements | 110 | 69 |
| Calcium channel blockers | 65 | 39 |
Use of concomitant compounds were collected at 6 months (Visit 2)
| Participants | Follow-Up Set Visit 2 (6 Months) |
|---|---|
| Diuretics - without mineral corticoid antagonists | 581 |
| Beta blocking agents | 533 |
| Agents acting on the renin-angiotensin system | 476 |
| Diuretics - mineral corticoid antagonists | 423 |
| Antithrombotic agents | 221 |
| Cardiac therapy | 238 |
| Lipid modifying agents | 92 |
| Mineral supplements | 65 |
| Calcium channel blockers | 35 |
For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters.
| Percentage of Patients | Follow-Up Set |
|---|---|
| Cardiologist's advice-No change | 45.1 |
| Cardiologist's advice-Treatment intensification | 30.7 |
| Cardiologist's advice-Treatment reduction | 6.3 |
| Cardiologist's advice-Treatment adaption | 17.9 |
NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, \> 1200 pg/ml).
| Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| <600 pg/ml | 495 | 0 |
| ≥ 600 pg/ml to <800 pg/ml | 135 | 130 |
| ≥ 800 pg/ml to <1000 pg/ml | 97 | 93 |
| ≥ 1000 pg/ml to <1200 pg/ml | 80 | 75 |
| ≥ 1200 pg/ml to <1400 pg/ml | 48 | 46 |
| ≥ 1400 pg/ml to <1600 pg/ml | 32 | 24 |
| ≥ 1600 pg/ml to <1800 pg/ml | 33 | 33 |
| ≥ 1800 pg/ml to <2000 pg/ml | 30 | 29 |
| ≥ 2000 pg/ml | 465 | 431 |
Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion.
| Percentage of Participants | Enrolled Set |
|---|---|
| Patients clinically stable | 96.9 |
| Patients not clinically stable | 3.1 |
| Patients suitable for prospective period of study | 63.2 |
| Patients not suitable for prospective period | 36.8 |
The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline.
| Number of Participants | Follow-Up Set |
|---|---|
| Western EU | 198 |
| Eastern EU | 525 |
At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline.
| pg/mL | Follow-Up Set |
|---|---|
| NT-proBNP [pg/ml] at Visit 1 (Baseline) | 2753 ± 2530 |
| NT-proBNP [pg/ml] at Visit 3 (10 months) | 2245 ± 2303 |
| Absolute change in NT-proBNP (V3-V1) | -504 ± 2607 |
Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF).
| Scores on a scale | Enrolled Set | Follow-Up Set |
|---|---|---|
| EQ-5D Visual Analog Scale (VAS) - Visit 1 | 60 (0 to 100) | 60 (0.0 to 100) |
| EQ5D Utility index - Visit 1 | 0.81 (-0.17 to 1.00) | 0.79 (-0.17 to 1.00) |
| EQ5D Utility index - Visit 2 | — | 0.80 (-0.11 to 1.00) |
| EQ5D Utility index absolute change (V2-V1) | — | 0.00 (-0.47 to 0.83) |
| EQ5D Utility index - Visit 3 | — | 0.78 (0.28 to 1.00) |
| EQ5D Utility index absolute change (V3-V1) | — | 0.00 (-0.82 to 0.80) |
The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure.
| Utility Index Score | Enrolled Set | Follow-Up Set |
|---|---|---|
| KCCQ Total Symptom Score - Visit 1 | 77.1 (0 to 100) | 74.0 (0 to 100) |
| KCCQ Clinical Summary Score - Visit 1 | 72.1 (0 to 100) | 68.8 (0 to 100) |
| KCCQ Overall Summary Score - Visit 1 | 70.1 (4.2 to 100) | 66.1 (4.2 to 100) |
| KCCQ Overall Summary Score absolute change (V2-V1) | — | 0.0 (-48.4 to 70.8) |
| KCCQ Overall Summary Score - Visit 3 | — | 66.7 (0.0 to 100) |
| KCCQ Overall Summary Score absolute change (V3-V1) | — | 0.5 (-66.1 to 66.8) |
| KCCQ Clinical Summary Score - Visit 2 | — | 68.8 (1.0 to 100.0) |
| KCCQ Clinical Summary Score abs. change (V2-V1) | — | 0.00 (-61.5 to 65.6) |
| KCCQ Clinical Summary Score - Visit 3 | — | 68.8 (0.0 to 100.0) |
| KCCQ Summary Score absolute change (V3-V1) | — | 0.0 (-53.1 to 69.0) |
Living conditions were collected at Baseline (Visit 1).
| Number of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Living independently in household (alone) | 313 | 204 |
| Living with spouse or significant other | 817 | 481 |
| Living in residence with other family member | 264 | 159 |
| Living in a long term care facility | 20 | 16 |
| Transient housing | 1 | 1 |
Employment status was collected at Baseline (Visit 1).
| Number of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Student | 0 | 0 |
| Employed (part-time) | 49 | 28 |
| Employed (full-time) | 144 | 51 |
| Homemaker | 26 | 15 |
| Retired | 1034 | 680 |
| Unemployed | 85 | 43 |
| Sustained Sick Leave | 73 | 40 |
| Missing | 4 | 4 |
Smoking status was collected at baseline (visit 1).
| Number of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Never | 779 | 500 |
| Current | 205 | 113 |
| Former | 427 | 246 |
| Missing | 4 | 2 |
Geographic regions were collected at Baseline (Visit 1).
| Number of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| RUS | 226 | 173 |
| BEL | 201 | 114 |
| HRV | 169 | 95 |
| SVN | 122 | 72 |
| POL | 120 | 74 |
| LTU | 103 | 65 |
| HUN | 94 | 58 |
| FRA | 89 | 54 |
| ESP | 76 | 30 |
| NOR | 58 | 33 |
| CYP | 36 | 20 |
| LVA | 34 | 22 |
| MLT | 26 | 17 |
| EST | 18 | 16 |
| DNK | 19 | 4 |
| PRT | 13 | 6 |
Health insurance status was collected at Baseline (Visit 1).
| Number of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Statutory Health Insurance | 1168 | 712 |
| Private Health Insurance | 29 | 22 |
| Combined statutory and private health insurance | 171 | 98 |
| None | 47 | 29 |
Educational level was collected at Baseline (Visit 1).
| Number of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Primary Education | 396 | 248 |
| Secondary Education | 730 | 421 |
| University | 257 | 173 |
| None | 30 | 17 |
| Missing | 2 | 2 |
The primary etiology of Heart Failure was collected at Baseline (Visit 1).
| Number of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Primary Etiology- Ischemic | 860 | 541 |
| Primary Etiology-Non-Ischemic | 553 | 320 |
HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline.
| Number of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Visit 1- Up to Baseline | 383 | 262 |
| Visit 2-6 months | 0 | 18 |
| Visit 3-10 months | 0 | 22 |
| Missing | 0 | 6 |
Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1)
| Percentage of Participants | Enrolled Set | Follow-Up Set |
|---|---|---|
| Hypertension | 74.2 | 75.8 |
| Dyslipidemia | 61.6 | 58.8 |
| History of myocardial infarction | 43.9 | 44.4 |
| Atrial fibrillation | 40.8 | 52.3 |
| Obesity | 36.1 | 30.8 |
| Stable angina pectoris | 31.4 | 33.8 |
| Diabetes mellitus type 2 | 29.9 | 31.5 |
| Other Comorbidities | 13.0 | 14.0 |
Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline
No measurements were reported for this outcome.
The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1).
| Number of Participants | Follow-Up Set |
|---|---|
| One ACEi or one ARB and one beta-blocker(V1) | 178 |
| Exactly one beta-blocker and one MRA(V1) | 166 |
| Exactly one ACEi or one ARB and one MRA(V1) | 165 |
| One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V1) | 82 |
| Exactly one beta-blocker and ARNi(V1) | 13 |
| Exactly one MRA and ARNi(V1) | 20 |
| Exactly one MRA and one beta-blocker and ARNi(V1) | 9 |
| One ACEi or one ARB and one beta-blocker(V2) | 156 |
| Exactly one beta-blocker and one MRA(V2) | 160 |
| Exactly one ACEi or one ARB and one MRA(V2) | 177 |
| One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V2) | 91 |
| Exactly one beta-blocker and ARNi(V2) | 17 |
| Exactly one MRA and ARNi(V2) | 23 |
| Exactly one MRA and one beta-blocker and ARNi(V2) | 10 |
| One ACEi or one ARB and one beta-blocker(V3) | 120 |
| Exactly one beta-blocker and one MRA(V3) | 130 |
| Exactly one ACEi or one ARB and one MRA(V3) | 143 |
| One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V3) | 77 |
| Exactly one beta-blocker and ARNi(V3) | 11 |
| Exactly one MRA and ARNi(V3) | 17 |
| Exactly one MRA and one beta-blocker and ARNi(V3) | 6 |
The duration of treatment with device type was collected at baseline (Visit 1)
No measurements were reported for this outcome.
Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected
| Percentage of participants | Follow-Up Set |
|---|---|
| Antithrombotic agents -≤1 and >3 years | 0.65 |
| Lipid modifying agents -≤1 and >3 years | 0.57 |
| Drugs for acid related disorders-≤1 and >3 years | 0.31 |
For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented.
No measurements were reported for this outcome.
Collected over Adverse Events were collected from FPFV to LPLV up to 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled Set | 32/1,415 (2.3%) | 117/1,415 (8.3%) | 187/1,415 (13.2%) |
| Follow-Up Set | 30/861 (3.5%) | 114/861 (13.2%) | 181/861 (21%) |
| Event | Enrolled Set | Follow-Up Set |
|---|---|---|
| Cardiac failureCardiac disorders | 29/1415 | 27/861 |
| Atrial fibrillationCardiac disorders | 9/1415 | 9/861 |
| PneumoniaInfections and infestations | 9/1415 | 9/861 |
| SyncopeNervous system disorders | 5/1415 | 5/861 |
| Myocardial infarctionCardiac disorders | 4/1415 | 4/861 |
| Cerebrovascular accidentNervous system disorders | 4/1415 | 4/861 |
| Acute myocardial infarctionCardiac disorders | 3/1415 | 3/861 |
| Diabetes mellitusMetabolism and nutrition disorders | 3/1415 | 3/861 |
| Acute kidney injuryRenal and urinary disorders | 3/1415 | 3/861 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 4/1415 | 3/861 |
| Event | Enrolled Set | Follow-Up Set |
|---|---|---|
| HeadacheNervous system disorders | 15/1415 | 15/861 |
| AnxietyPsychiatric disorders | 12/1415 | 12/861 |
| BronchitisInfections and infestations | 10/1415 | 10/861 |
| FatigueGeneral disorders | 9/1415 | 9/861 |
| Urinary tract infectionInfections and infestations | 9/1415 | 9/861 |
| Dyspnoea exertionalRespiratory, thoracic and mediastinal disorders | 9/1415 | 9/861 |
| Oedema peripheralGeneral disorders | 8/1415 | 8/861 |
| Back painMusculoskeletal and connective tissue disorders | 8/1415 | 8/861 |
| Chest painGeneral disorders | 7/1415 | 7/861 |
| AnaemiaBlood and lymphatic system disorders | 6/1415 | 6/861 |
| Age, Continuous(Years) | Enrolled Patients |
|---|---|
| Mean | 69.8 ± 11.6 |
| Age, Customized(Participants) | Enrolled Patients |
|---|---|
| <65 years | 482 |
| ≥65 years to <75 years | 408 |
| ≥75 years to <85 years | 401 |
| ≥85 years | 124 |
| Sex: Female, Male(Participants) | Enrolled Patients |
|---|---|
| Female | 436 |
| Male | 979 |
| Race (NIH/OMB)(Participants) | Enrolled Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 1282 |
| More than one race | 0 |
| Unknown or Not Reported | 126 |
Showing the first 100 of 191 sites across 18 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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