An interventional study of Heart Failure network care in Heart Failure - NYHA II - IV, sponsored by University of Leipzig. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University of Leipzig · Not applicable, Interventional, and Treatment
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.
See above.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Leipzig is the lead sponsor of 148 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 usual care by their primary physician or cardiologist
Patients not willing to be randomised will be followed in a registry.
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
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
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
Plan to share: Yes — Individual patient data will be shared following reasonable scientific request
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Oct 2028, 46 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 46 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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