Heart Failure - NYHA II - IVPEDAL-HFNCT06656832
Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
A study testing Heart Failure network care in people with Heart Failure - NYHA II - IV, run by University of Leipzig at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure - NYHA II - IV
- What is being tested?
- Heart Failure network care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 28 Nov 2024to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age <18 years
- pregnancy
- any condition interfering with the informed consent process
- patients placed in an institution by official or court order
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sophie Charlotte Schröder, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Leipzig
Leipzig
Charlotte Sophie Schröder, MD, +49 341 97 12650, SophieCharlotte.Schroeder@medizin.uni-leipzig.de
Rolf Wachter, MD, rolf.wachter@medizin.uni-leipzig.de
About this study
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.
Read the detailed description
See above.
- Conditions
- Heart Failure - NYHA II - IV
- Being tested
- Heart Failure network care
- Keywords
- Heart Failure Network Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure network careOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NT-proBNP plasma levels between baseline and 6 months visit
Adjusted geometric mean ratio between 6 months visit and baseline visit
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start28 Nov 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure - NYHA II - IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656832
- Sponsor's protocol ID
- 242/24-ek
- Other IDs
- 934700-034
- Acronym
- PEDAL-HF
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be shared following reasonable scientific request