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

Phase 1

• Conditions: Chronic heart failure with reduced ejection fraction; MedDRA version: 19.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-000473-20-HR
• Lead Sponsor: ovartis Pharma services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-15
• Study Completion: 2018-03-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1415

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified