I21
Conditions
Interventions
Group 1: Intermittent Fasting (time-restricted feeding
at least 16 hours fasting, not more than 8 hours unrestricted diet) for three months
then voluntary continuation of intermittent fasting or cross-over for three more months
Group 2: Control (no specific dietary restrictions) for three months, the voluntary cross-over or three more mon
Sponsors
Universitätsklinikum Halle (Saale)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - written informed consent - ST-elevation myocardial infarction (or equivalent)
Exclusion criteria
Exclusion criteria: - missing informed consent - participation in other clinical trials - patients with cardiac devices not approved for MRI scanning - kidney failure (GFR <30 ml/min) - claustrophobia - antidiabetic therapy with sulfonylurea - pregnancy - employees of the study center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular myocardial function at four weeks after randomization (evaluated by echocardiography) | — |
Secondary
| Measure | Time frame |
|---|---|
| - all-cause hospitalization - hospitalization from cardiovascular cause - all-cause death - death from cardiovascular cause - myocardial infarction - revascularisation - stroke - patient weight - blood pressure - medication - comorbidities - left ventricular function at three and six months after randomization - further characterization of myocardial function evaluated by echocardiography (i.e. Kinetikstörungen, LVEDP, E/e‘) - myocardial scar and edema (evaluated by cardiac MRI) - clinical chemistry and hematology (hGH, adiponectine, NT-proBNP, creatinine, fasting insulin, fasting blood glucose, HbA1c, blood count, IL-1, IL-6, C-reactive protein, homocysteine, cholesterine, LDL, HDL, triglycerides) - Peripheral Blood Mononuclear Cells - DNA-Methylation of circulating cells („epigenetic clock“) Follow-up: 6 months. Study visits at regular ambulatory visits at 4 weeks, 3 months, and 6 months | — |
Countries
Germany
Contacts
Public ContactJochen Dutzmann
Universitätsklinikum Halle (Saale)
Outcome results
None listed