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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
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
University Hospital Leipzig
Leipzig, Germany
RECRUITINGChange 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
Sophie Charlotte Schröder, MD
CONTACT
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