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Clinical Trial NCT06656832 (PEDAL-HF) for Heart Failure - NYHA II - IV is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of LeipzigPeripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study 1,000 Randomized Paid Participation
Clinical Trial NCT06656832 (PEDAL-HF) is an interventional study for Heart Failure - NYHA II - IV and is currently not yet recruiting. Enrollment is planned to begin on 1 November 2024 and continue until the study accrues 1,000 participants. Led by University of Leipzig, this study is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 24 October 2024.
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...Show More
Detailed Description
See above.
Official Title
Peripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study
Conditions
Heart Failure - NYHA II - IVOther Study IDs
- PEDAL-HF
- 242/24-ek
- 934700-034 (Other Identifier) (Universität Leipzig)
NCT ID Number
Start Date (Actual)
2024-11-01
Last Update Posted
2024-10-24
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
1,000
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Heart Failure Network Care
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRandomised Arm 1: Heart Failure Network Care Patients will receive three follow-up visits during the vulnerable period (three month after hospital discharge) in the HF network (either cardiologist in private practice or HF outpatient clinic) | Heart Failure Network Care Patients will receive three visits within the first three months after randomization for improving heart failure therapy at a cardiologist or the outpatient heart failure clinic |
No InterventionRandomised Arm 2: Usual care Patients will receive usual care by their primary physician or cardiologist | N/A |
No InterventionRegistry Arm for non-randomised patients Patients not willing to be randomised will be followed in a registry. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in NT-proBNP plasma levels between baseline and 6 months visit | Adjusted geometric mean ratio between 6 months visit and baseline visit | 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in KCCQ from baseline to 6 months of Follow-up | Quality of life measured by Kansas City Cardiomyopathy Questionnaire | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- Age < 18 years, pregnancy, any condition interfering with the informed consent process, patients placed in an institution by official or court order
University of Leipzig68 active studies to exploreStudy Central Contact
Contact: Rolf Wachter, MD, +49-341-97-12650, [email protected]
Contact: Sophie Charlotte Schröder, MD, +49-341-97-12650, [email protected]
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