Inflammatory Cardiomyopathy I51.4
Conditions
Interventions
Group 1: Intervention group (3 cycles of the ProLon™ fast-mimicking diet)
Group 2: Control group (regular diet)
Group 3: Control group after cross-over (3 cycles of the ProLon™ fast-mimicking diet a
Sponsors
Medizinische Klinik für Kardiologie am Campus Benjamin Franklin der Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Ability and willingness to provide written informed consent; 2. Ability and willingness to do the study tests; 3. Diagnosed with inflammatory cardiomyopathy based on myocardial biopsy
Exclusion criteria
Exclusion criteria: 1. Systolic blood pressure 10 mg daily) (based on medical history provided at screening); 12. Cancer diagnosis; 13. Unintentional weight loss >5% in the preceding 6 months 14. Uncontrolled severe hypertension (SBP/DBP >180/100) 15. Females who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shifts in the composition of inflammatory parameters (i.e. Th1-cytokines, Th17-cytokines, regulatory t-cells & naive t-cells) in the peripheral blood after 3 months of diet (regular vs. fast-mimicking diet), detected by means of FACS-analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| After 3 months of diet: Improvement of left ventricular ejection fraction; Decrease in ectopic beats and arrhythmias on 24 h Holter monitoring; Improved performance on exercise stress testing; Improvement of cardiac markers: High sensitivity Troponin T, myoglobin, NT-proBNP; Change in lifestyle and quality of life evaluated through Kansas City Cardiomyopathy Questionnaire (KCCQ) | — |
Countries
Germany
Contacts
Public ContactBettina Heidecker
Klinik für Kardiologie, Charité, Campus Benjamin Franklin
Outcome results
None listed