Heart Failure - NYHA II - IV
Conditions
Keywords
Heart Failure Network Care
Brief 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. 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.
Interventions
OTHERHeart Failure network care
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
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The primary endpoint (NT-proBNP) will be measured by lab personnel blinded to patients´ group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Age \<18 years * pregnancy * any condition interfering with the informed consent process * patients placed in an institution by official or court order
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NT-proBNP plasma levels between baseline and 6 months visit | 6 months | Adjusted geometric mean ratio between 6 months visit and baseline visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in KCCQ from baseline to 6 months of Follow-up | 6 months | Quality of life measured by Kansas City Cardiomyopathy Questionnaire. This score has values between 0 and 100 and higher values reflect better health status. |
Countries
Germany
Contacts
CONTACTRolf Wachter, MD
CONTACTSophie Charlotte Schröder, MD
Outcome results
None listed