NCT06656832 Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
| NCT ID | NCT06656832 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leipzig |
| Condition | Heart Failure - NYHA II - IV |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-11-28 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-11-28 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
PEDAL-HF is a registry-based randomized prospective multicenter study. The investigators 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06656832 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure - NYHA II - IV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06656832 currently recruiting?
Yes, NCT06656832 is actively recruiting participants. Contact the research team at rolf.wachter@medizin.uni-leipzig.de for enrollment information.
Where is the NCT06656832 trial being conducted?
This trial is being conducted at Leipzig, Germany.
Who is sponsoring the NCT06656832 clinical trial?
NCT06656832 is sponsored by University of Leipzig. The trial plans to enroll 1,000 participants.
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