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| ID | Type | Description | Link |
|---|---|---|---|
| 934700-034 | Other Identifier | Universität Leipzig |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart Failure network care | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NT-proBNP plasma levels between baseline and 6 months visit | Adjusted geometric mean ratio between 6 months visit and baseline visit | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rolf Wachter, MD | Contact | +49-341-97-12650 | rolf.wachter@medizin.uni-leipzig.de | |
| Sophie Charlotte Schröder, MD | Contact | +49-341-97-12650 | sophiecharlotte.schroeder@medizin.uni-leipzig.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leipzig | Recruiting | Leipzig | Germany |
Individual patient data will be shared following reasonable scientific request
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The primary endpoint (NT-proBNP) will be measured by lab personnel blinded to patients´ group assignment
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