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

NCT ID: NCT06656832

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2028-12-31

Brief Summary

PEDAL-HF is a registry-based randomized prospective multicenter study. We 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.

Conditions

Heart Failure - NYHA II - IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Heart Failure network care

Intervention Type: 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 2: Usual care

Patients will receive usual care by their primary physician or cardiologist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Registry Arm for non-randomised patients

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Rolf Wachter, MD

Role: CONTACT

rolf.wachter@medizin.uni-leipzig.de

+49-341-97-12650

Sophie Charlotte Schröder, MD

Role: CONTACT

sophiecharlotte.schroeder@medizin.uni-leipzig.de

+49-341-97-12650

Other Identifiers

934700-034

Identifier Type: OTHER

Identifier Source: secondary_id

242/24-ek

Identifier Type: -

Identifier Source: org_study_id