Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
Recruiting · NCT06656832 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Leipzig
View the official record on ClinicalTrials.gov →Interventions studied
Heart Failure network care
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- University Hospital Leipzig - Leipzig, Germany