I50
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Disease definition according to established guidelines: HFpEF is defined as a sign and symptom of heart failure with a left ventricular ejection fraction of =50%
Exclusion criteria
Exclusion criteria: • Refusal to participate in the study • Lack of capacity to consent • Cardiovascular event less than 6 months ago • Active malignant diseases • Persons with cardiac pacemakers • Taurine supplementation in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow-mediated vasodilation (FMD, µm/%) of the brachial artery, measured with UNEX EF 38G before and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints (before and after treatment): - Reactive hyperemia index (RHI), measured by plethysmography on the index finger using EndoPat 2000 - Diastolic cardiac function and global strain of the left atrium and left ventricle, measured by echocardiography - Systolic function and atrial size, measured by echocardiography - Intima-media thickness (mm), measured by Doppler duplex ultrasonography - Maximum oxygen uptake (VO2max), performance (watts), and exercise duration, measured using spiroergometry - 14-day activity profile with step count, activity intensity, sleep duration, and energy consumption (activity counts), measured using actigraphy - Heart rate (bmp), as well as systolic, diastolic and mean arterial blood pressure (mmHg), measured once using Philips EarlyVue VS30 vital signs monitor and measured over 24 h using ABPMpro for day and night mean values - PWV (m/s), measured once with PulsePen and over 24 h using ABPMpro for day and night mean values - NT-proBNP (ng/l), troponin values (ng/l), CRP (mg/dl), glucose (mg/dl) and HbA1c (%), triglycerides (mg/dl), HDL-/LDL-/ total cholesterol (mg/dl), taurin (µmol/l) measured in blood (fasting) - Creatinine (mg/dl), measured in spontaneous urine - Cardiopulmonary endurance, measured as walking distance in the 6-minute walk test (m) - Hand grip strength (kg), measured with dynamometer - Total body water, fat mass, fat-free mass, phase angle, resistance and reactance, measured using bioimpedance analysis and air displacement plethysmography - 24 h blood glucose profile and response to oral glucose tolerance test (mmol/l), measured by blood glucose sensor - Retinal vessel density (ONH perfusion, %), measured using optical coherence tomography (OCT-A) - Pathological changes in the peripheral retina, such as hemorrhages, exudates or vascular anomalies, detected by funduscopy - Dilatation capacity of retinal vessels (%) when stimulated with flicker light, measured with Dynamic Vessel Analyzer | — |
Countries
Germany
Contacts
Charité Universitätsmedizin Berlin