Peripheral factors that drive heart failure progression (PEDAL-HF)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PEDAL-HF is a registry-based, randomized, prospective multicenter trial planning to enroll about 1,000 patients hospitalized with acute decompensated heart failure at five tertiary heart clinics in Germany. In the randomized component, 750 participants will be assigned to either care within a structured heart-failure network or to usual care, with the primary randomized endpoint being change in NT-proBNP from baseline to six months. All enrolled patients, randomized or not, will be followed for two years to capture longer-term outcomes and healthcare use. The design combines registry enrollment with randomized assignment to test whether coordinated networked care changes biomarker trajectories and the clinical course of heart failure.

Why it matters

Who can join: the full rules

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's running

• University Hospital Leipzig
  Leipzig, Germany Recruiting

Study contacts

• Study coordinator: Rolf Wachter, MD
• Email: rolf.wachter@medizin.uni-leipzig.de
• Phone: +49-341-97-12650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.