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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure - NYHA II - IV
• Intervention / Treatment: Other: Heart Failure network care

Detailed Description

See above.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rolf Wachter, MD; Phone Number: +49-341-97-12650; Email: rolf.wachter@medizin.uni-leipzig.de
• Study Contact Backup: Name: Sophie Charlotte Schröder, MD; Phone Number: +49-341-97-12650; Email: sophiecharlotte.schroeder@medizin.uni-leipzig.de

Study Locations

• Germany
  • Leipzig, Germany
    • Recruiting
    • University Hospital Leipzig
    • Contact: Charlotte Sophie Schröder, MD; Phone Number: +49 341 97 12650; Email: SophieCharlotte.Schroeder@medizin.uni-leipzig.de
    • Contact: Rolf Wachter, MD; Email: rolf.wachter@medizin.uni-leipzig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomised Arm 1: Heart Failure Network Care; Patients will receive three follow-up visits during the vulnerable period (three month after hospital discharge) in the HF network (either cardiologist in private practice or HF outpatient clinic)	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
No Intervention: Randomised Arm 2: Usual care; Patients will receive usual care by their primary physician or cardiologist
No Intervention: Registry Arm for non-randomised patients; Patients not willing to be randomised will be followed in a registry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NT-proBNP plasma levels between baseline and 6 months visit	Adjusted geometric mean ratio between 6 months visit and baseline visit	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in KCCQ from baseline to 6 months of Follow-up	Quality of life measured by Kansas City Cardiomyopathy Questionnaire. This score has values between 0 and 100 and higher values reflect better health status.	6 months

Collaborators and Investigators

• Sponsor: University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure Network Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 242/24-ek; 934700-034 (Other Identifier: Universität Leipzig)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient data will be shared following reasonable scientific request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No