Peripheral factors that drive heart failure progression (PEDAL-HF)
Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
This trial will test whether heart-failure network care helps people recently hospitalized with acute decompensated heart failure (NYHA II–IV) improve biomarker levels and clinical outcomes compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 1 site (Leipzig) |
| Trial ID | NCT06656832 on ClinicalTrials.gov |
What this trial studies
PEDAL-HF is a registry-based, randomized, prospective multicenter trial planning to enroll about 1,000 patients hospitalized with acute decompensated heart failure at five tertiary heart clinics in Germany. In the randomized component, 750 participants will be assigned to either care within a structured heart-failure network or to usual care, with the primary randomized endpoint being change in NT-proBNP from baseline to six months. All enrolled patients, randomized or not, will be followed for two years to capture longer-term outcomes and healthcare use. The design combines registry enrollment with randomized assignment to test whether coordinated networked care changes biomarker trajectories and the clinical course of heart failure.
Who should consider this trial
Good fit: Ideal candidates are adults (18 years or older) recently admitted with acute decompensated heart failure (NYHA II–IV) with objective structural cardiac abnormalities who can provide informed consent and are not pregnant.
Not a fit: Patients under 18, pregnant individuals, those unable to consent, people institutionalized by court order, or those with stable non-decompensated heart failure are unlikely to receive benefit from the network intervention.
Why it matters
Potential benefit: If successful, networked heart-failure care could lower NT-proBNP, reduce rehospitalizations, and improve symptom control by coordinating specialized follow-up.
How similar studies have performed: Previous disease-management and heart-failure network programs have demonstrated improvements in readmission rates and quality of care, and this trial builds on that evidence using a registry-based randomized format.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leipzig
- University Hospital Leipzig — Leipzig, Germany (Recruiting)
Study contacts
- Study coordinator: Rolf Wachter, MD
- Email: rolf.wachter@medizin.uni-leipzig.de
- Phone: +49-341-97-12650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.