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Intermittent fasting in heart failure with preserved ejection fractio

Not Applicable
Recruiting
Conditions
I50
Heart failure
Registration Number
DRKS00028261
Lead Sponsor
niversitätsklinikum Halle (Saale)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
82
Inclusion Criteria

Written informed consent; chronic heart failure (NYHA II-IV) with preserved ejection fraction (HFA-PEFF-Score =5 Punkte)

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Difference in walking distance in 6-minute-walking-test (6-MWT) after 3 month compared to baseline walking distance in 6-MWT
Secondary Outcome Measures
NameTimeMethod
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).
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