E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic heart failure with reduced ejection fraction |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019279 |
E.1.2 | Term | Heart failure |
E.1.2 | System Organ Class | 100000004849 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess if NT-proBNP measurement-guided cardiologist-referral of CHF patients, who are currently judged by their primary care physician as being clinically stable, leads to optimization of HF treatment, defined as adherence to level I-A treatment recommendations of the current ESC guidelines for the treatment of HF. |
|
E.2.2 | Secondary objectives of the trial |
-Describe the blood levels of NT-proBNP in CHF patients managed in primary care setting and to characterize the change after optimization of therapy
-Describe the baseline demographic, clinical characteristics, pharmacological and device treatment of CHF patients managed in the primary care setting
-Assess in stable patients the impact of patient's key baseline characteristics on the prescription practice for HF treatment and the adherence of these treatment choices to the recommendations (ESC guidelines)
-Describe the proportion of CHF patients managed in the primary care setting considered stable
- Describe local prescription practice of cardiologists for the treatment of stable CHF patients.
- Describe local prescription practice and decision making of primary care physicians for the treatment of stable CHF patients.
- Characterize how treatment optimization affects NT-proBNP levels in stable CHF patients
-Assess the baseline health-related quality of life in CHF patients |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Willing and able to provide written informed consent and accept study procedures and time schedule.
- Age ≥ 18 years.
- Patients suffering from chronic heart failure whose diagnosis has been made or confirmed by a cardiologist and/or hospital physician.
- Patients with reduced ejection fraction (LVEF ≤ 40%). |
|
E.4 | Principal exclusion criteria |
- Use of investigational drugs within 5 half-lives of enrollment, or within 30 days /until the expected pharmacodynamic effect has returned to baseline.
- Major surgery in the last 3 months or planned/foreseeable major surgery or cardiac intervention during the study.
- Cancer or other significant co-morbidities implying that the patient’s condition is unstable.
- Comorbidities that can be associated with elevated natriuretic peptide (NP) levels, recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.
- Patients who are primarily managed and regularly followed-up by a cardiologist for their HF.
- Highly frail patients whose estimated lifespan due to comorbidities is less than 6 months.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change of the proportion of clinically stable patients whose therapy regimen adheres to ESC guideline recommendations before and after specialist referral. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Demographics, Clinical features, Pharmacological / device treatment of HF
- Proportion of clinically stable patients for whom the cardiologist and/or primary care physician optimizes treatment post referral, stratified according to key baseline characteristics
- NT-proBNP in CHF patients managed in primary care setting, change of NT-proBNP levels in clinically stable CHF patients with and without treatment optimization
- Proportion of clinically stable patients
-Description of cardiologist prescription practice per country/region
- Description of primary care physicians’ prescription practice per country/region
- NT-proBNP levels in clinically stable patients
- Change of EQ-5D and KCCQ total and individual sub-scores
- Baseline EQ-5D and KCCQ total and individual sub-scores |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Demographics, Clinical features, Pharmacological/device treatment of HF: Baseline (Visit 1), Visit 2 and 3
- Proportion of clinically stable patients for whom the cardiologist and/or primary care physician optimizes treatment post referral, stratified according to key baseline characteristics: Visit 2 and 3
- NT-proBNP: Visit 1
- Proportion of clinically stable patients: Visit 1
-Description of cardiologist prescription practice per country/region: Visit 2
- Description of primary care physicians’ prescription practice per country/region: Visit 1, 2 and 3
- NT-proBNP levels in clinically stable patients: Visit 1 and 3
- Change of EQ-5D and KCCQ total and individual sub-scores between: Visit 1, 2 and 3
- Baseline EQ-5D and KCCQ total and individual sub-scores: Visit 1, 2 and 3 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
A prospective evaluation of natriuretic peptide based referral of CHF patients in primary care.
|
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
low-interventional, prospective, observational study |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 26 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 600 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Croatia |
Cyprus |
Denmark |
Estonia |
France |
Germany |
Hungary |
Israel |
Italy |
Latvia |
Lithuania |
Malta |
Norway |
Poland |
Portugal |
Russian Federation |
Slovakia |
Slovenia |
Spain |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LPLV = Last Patient Last Visit |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 11 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 11 |