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

NCT06656832 | Recruiting

• 2 other identifiers: 242/24-ek934700-034
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure - NYHA II - IV

Keywords

Heart Failure Network Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 months

Study Arms (3)

Randomised Arm 1: Heart Failure Network Care

EXPERIMENTAL

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

Randomised Arm 2: Usual care

NO INTERVENTION

Patients will receive usual care by their primary physician or cardiologist

Registry Arm for non-randomised patients

NO INTERVENTION

Patients not willing to be randomised will be followed in a registry.

Interventions

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

Randomised Arm 1: Heart Failure Network Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \<18 years
• pregnancy
• any condition interfering with the informed consent process
• patients placed in an institution by official or court order

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Hospital Leipzig

Leipzig, Germany

RECRUITING

Central Study Contacts

Rolf Wachter, MD

CONTACT

+49-341-97-12650; rolf.wachter@medizin.uni-leipzig.de

Sophie Charlotte Schröder, MD

CONTACT

+49-341-97-12650; sophiecharlotte.schroeder@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The primary endpoint (NT-proBNP) will be measured by lab personnel blinded to patients´ group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: November 28, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)