Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06656832

Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Failure - NYHA II - IV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart Failure network care

Other

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 outcomes

  1. Change in NT-proBNP plasma levels between baseline and 6 months visit

    Time frame: 6 months

    Adjusted geometric mean ratio between 6 months visit and baseline visit

Secondary outcomes

  1. Change in KCCQ from baseline to 6 months of Follow-up

    Time frame: 6 months

    Quality of life measured by Kansas City Cardiomyopathy Questionnaire. This score has values between 0 and 100 and higher values reflect better health status.

Study contacts

Contact information is provided by the study sponsor or research team.

Rolf Wachter, MD

CONTACT

[email protected]

+49-341-97-12650

Sophie Charlotte Schröder, MD

CONTACT

[email protected]

+49-341-97-12650

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Acronym: PEDAL-HF

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 24, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.