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

University of Leipzig

Status: Not yet enrolling

Conditions: Heart Failure - NYHA II - IV

Treatments: Other: Heart Failure network care

Study type: Interventional

Funder types: Other

Identifiers

NCT06656832

934700-034 (Other Identifier)

242/24-ek

Details and patient eligibility

About

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.

Full description

See above.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 3 patient groups

Randomised Arm 1: Heart Failure Network Care

Experimental group

Description:

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)

Treatment:

Other: Heart Failure network care

Randomised Arm 2: Usual care

No Intervention group

Description:

Patients will receive usual care by their primary physician or cardiologist

Registry Arm for non-randomised patients

No Intervention group

Description:

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