Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
University Hospital Leipzig
RECRUITING
Leipzig
Contact Information
Primary
Rolf Wachter, MD
rolf.wachter@medizin.uni-leipzig.de
+49-341-97-12650
Backup
Sophie Charlotte Schröder, MD
sophiecharlotte.schroeder@medizin.uni-leipzig.de
+49-341-97-12650
Time Frame
Start Date: 2024-11-28
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1000
Treatments
Experimental: Randomised 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)
No_intervention: Randomised Arm 2: Usual care
Patients will receive usual care by their primary physician or cardiologist
No_intervention: Registry Arm for non-randomised patients
Patients not willing to be randomised will be followed in a registry.
Related Therapeutic Areas
Sponsors
Leads: University of Leipzig