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

ConditionHeart Failure - NYHA II - IV

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Leipzig

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age <18 years

pregnancy

any condition interfering with the informed consent process

patients placed in an institution by official or court order

Trial design

Design model

Parallel

Treatments tested in this trial

Heart Failure network care
Other intervention
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

Treatment groups

1,000 Participants

are divided into 3 treatment groups

Group A: Randomised Arm 1: Heart Failure Network CareExperimental treatment 1 intervention

Group B: Randomised Arm 2: Usual careNo intervention 0 interventions

Group C: Registry Arm for non-randomised patientsNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Adjusted geometric mean ratio between 6 months visit and baseline visit

Time frame

6 months

Secondary outcomes

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.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leipzig

Lead sponsor

Source ClinicalTrials.gov

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