Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
ConditionHeart Failure - NYHA II - IV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leipzig
About this trial
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
Qualifiers
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.
Disqualifiers
Age <18 years
pregnancy
any condition interfering with the informed consent process
patients placed in an institution by official or court order
Trial design
Treatments tested in this trial
- Heart Failure network care
Treatment groups
1,000 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov