I50
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Written informed consent; chronic heart failure (NYHA II-IV) with preserved ejection fraction (HFA-PEFF-Score =5 Punkte)
Exclusion criteria
Exclusion criteria: no written informed consent; not able to give a written informed consent; simultaneously participating in another intervention trial; anti-diabetic therapy with sulfonylurea; pregnancy; employment relationship or any other relationship of dependence with the study site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in walking distance in 6-minute-walking-test (6-MWT) after 3 month compared to baseline walking distance in 6-MWT | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in 6-minute walk test (6-MWT) distance at 6 months compared with baseline 6-MWT distance; hospitalization due to heart failure; hospitalization due to any cardiovascular cause; hospitalization due to any cause; death due to any cause; death due to cardiovascular cause; quality of life (assessed by the Short Kansas Cardiomyopathy Questionnaire, KCCQ-12); hypoglycemia; body weight; BMI; waist-to-hip ratio; blood pressure; (pre)medication; comorbidities (esp. diabetes mellitus); echocardiographic parameters (e.g. e', E/e', LAVI, TR velocity, GLS, LVMI, RWT, IVSd, electromechanical delay, LA strain); endothelial function (via pulse amplitude tonometry); Laboratory parameters (hGH, adiponectin, NT-proBNP, creatinine, fasting insulin, fasting blood glucose, HbA1c, differential blood count, IL-6, C-reactive protein, homocysteine, cholesterol, LDL, HDL, triglycerides); circulating immune cells; DNA methylation of circulating cells ("epigenetic clock"). | — |
Countries
Germany
Contacts
Universitätsklinikum Halle (Saale) Klinik für Innere Medizin III