A prospective evaluation of natriuretic peptide based referral of chronic heart failure patients in primary care

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2016-000473-20-HR
• Date of registration: 15/12/2016
• Prospective Registration: No
• Primary sponsor: Novartis Pharma services AG
• Public title: A prospective evaluation of natriuretic peptide based referral of chronic heart failure patients in primary care
• Scientific title: A prospective evaluation of natriuretic peptide based referral of CHF patients in primary care - PREFER
• Date of first enrolment: 18/08/2016
• Target sample size: 4000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000473-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: low-interventional, prospective, observational study; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Russian Federation, Slovakia, Slovenia, Spain

Contacts

• Name: Medicinski odjel
• Affiliation: Novartis Hrvatska d.o.o.

• Name: Medicinski odjel
• Affiliation: Novartis Hrvatska d.o.o.

Key inclusion & exclusion criteria

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%).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2400

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Chronic heart failure with reduced ejection fraction
MedDRA version: 19.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849

Intervention(s)

Pharmaceutical Form:

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline, Visit 2

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.

Secondary Objective: -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

Main Objective: 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.

Secondary Outcome(s)

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

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

Secondary ID(s)

CLCZ696B3402

Source(s) of Monetary Support

Novartis Pharma services AG

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 07/04/2019
• Date Completed: 23/03/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000473-20/results