Heart Failure with preserved Ejection Fraction (HFpEF)
Conditions
Interventions
Group 1: Standard treatment for HFpEF including a consultation and medical examination
Group 2: Supplementing standard treatment with a 12-week app-based, personalised exercise coaching
Sponsors
Medizinische Fakultät Heidelberg / Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: • Diagnosis of HFpEF - LVEF > 40% by any imaging modality within the last 4 months - Current HF symptoms as defined as presence of dyspnea according to New York Heart Association [NYHA] functional class I to III - Stable HF treatment for at least 4 weeks prior to screening - At least one of the following criteria: ? NT-proBNP = 300pg/ml ? Hospitalization for HF within the past 12 months ? Symptom(s) of HF requiring treatment with diuretic(s) for at least 30 days prior to screening visit • Physically capable of performing Cardiopulmonary Exercise Testing (CPET) and spirometry • Average daily step count during baseline assessment = 1,000 steps per day and < 10,000 steps per day • Capacity to provide informed consent
Exclusion criteria
Exclusion criteria: • Acutely decompensated HF requiring intensified therapy • Participants who are managed non-ambulatory or use mobility assist devices • Acute coronary syndrome (including myocardial infarction), cardiac surgery, other major cardiovascular surgery or urgent percutaneous coronary intervention (PCI) within 3 months prior to visit 1 or an elective PCI within 30 days after study enrolment • Participants with physical activity impairment primarily due to conditions other than HF • Current chemotherapy and/or radiation therapy for treatment of active cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is defined by the demonstration of intervention effects in at least one of two primary endpoints: (1) change in physical activity (daily step count) between baseline and the end of the intervention, comparing standard care with a 12-week exercise programme. (2) Change in maximum oxygen consumption (VO2 peak) between baseline and the end of the intervention, comparing standard care with a 12-week exercise programme. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effects of a 12-week exercise training program on cardiovascular and aerobic fitness compared to standard care on parameters of: • Cardiovascular and pulmonary system (cardiac Magnetic Resonance Imaging [MRI], echocardiography, spirometry) • Muscle function • Metabolism • Neurohumoral activation • Autonomic function (heart rate variability [HRV]) • Six-minute walking distance (6MWD) • Exercise capacity (cardiopulmonary exercise testing [CPET]) • Non-sedentary daytime activities (Accelerometry) • Mental health [PHQ-9, GAD-7] • Fatigue [MFI-20] • Quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ] | — |
Countries
Germany
Contacts
Public ContactNorbert Frey
Innere Medizin III, Universitätsklinikum Heidelberg
Outcome results
None listed