Peripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study
Not Applicable
Not yet recruiting
- Conditions
- Heart Failure - NYHA II - IV
- Registration Number
- NCT06656832
- Lead Sponsor
- University of Leipzig
- Brief Summary
PEDAL-HF is a registry-based randomized prospective multicenter study. We plan to include 1000 patients who were recently admitted with acute decompensated heart failure at five tertiary heart clinics in Germany. For the randomised part, 750 patients will be randomized to care within a heart failure network or usual care. The primary endpoint of the randomized trial is change in NT-proBNP from baseline to 6 months of follow-up.
All patients (randomized or not) will be followed for two years.
- Detailed Description
See above.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Patients admitted to the participating study centres with acute decompensated heart failure (ADHF), defined as clinical signs and/or symptoms of heart failure, objective structural cardiac abnormalitites according to the ESC criteria.
Exclusion Criteria
- Age < 18 years, pregnancy, any condition interfering with the informed consent process, patients placed in an institution by official or court order
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in NT-proBNP plasma levels between baseline and 6 months visit 6 months Adjusted geometric mean ratio between 6 months visit and baseline visit
- Secondary Outcome Measures
Name Time Method Change in KCCQ from baseline to 6 months of Follow-up 6 months Quality of life measured by Kansas City Cardiomyopathy Questionnaire