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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
- ClinicalTrials.gov ID
- NCT06656832
- Acronym / sponsor ID
- PEDAL-HF / 242/24-ek
- Conditions
- Heart Failure - NYHA II - IV
- Keywords
- Heart Failure Network Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomised Arm 1: Heart Failure Network Care | Experimental | Other: Heart Failure network carePatients 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) |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Age <18 years
- pregnancy
- any condition interfering with the informed consent process
- patients placed in an institution by official or court order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Failure network carePatients 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 | Other | Randomised Arm 1: Heart Failure Network Care |
Primary outcome
Change in NT-proBNP plasma levels between baseline and 6 months visit
Time frame: 6 months
Adjusted geometric mean ratio between 6 months visit and baseline visit
1 secondary outcome
Change in KCCQ from baseline to 6 months of Follow-up
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. Individual patient data will be shared following reasonable scientific request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Charlotte Schröder, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rolf Wachter, MD (+49-341-97-12650, rolf.wachter@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NT-proBNP plasma levels between baseline and 6 months visit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.