Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heart Failure network care.
- Who it may be relevant to
- Registry conditions: Heart Failure - NYHA II - IV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
See above.
Interventions
- Other 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
Primary outcome measures
- Change in NT-proBNP plasma levels between baseline and 6 months visit [Time frame: 6 months]
Secondary outcome measures (1)
- Change in KCCQ from baseline to 6 months of Follow-up [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Hospital Leipzig — Leipzig
Identifiers
NCT: NCT06656832 · 242/24-ek · 934700-034