Randomized, Controlled Pilot-Study to Evaluate the Safety and immune regulatory effect of ProLon®, a Fasting-Mimicking Diet (FMD), on Inflammatory Cardiomyopathy (CMP)

Not Applicable

Recruiting

• Conditions: Inflammatory Cardiomyopathy; I51.4; Myocarditis, unspecified

• Registration Number: DRKS00019897
• Lead Sponsor: Medizinische Klinik für Kardiologie am Campus Benjamin Franklin der Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

1. Systolic blood pressure <90 mmHg and/or diastolic pressure <50 mmHg (measured at screening);
2. History of gastric bypass (based on medical history provided at screening);
3. Type 1 diabetes (based on medical history provided at screening);
4. Taking insulin, insulin analogs, or octreotide (based on medical history provided at screening);
5. Receiving medications for diabetes: DDP-4 inhibitors, GLP-1 agonists, Sulfonylureas, Meglitinides, D-Phenylalanine Derivatives, Thiazolidinediones Pioglitazone (TZDs) Alpha-glucosidase Inhibitors, Bile Acid Sequestrants, Combination Pills, Insulin (based on medical history provided at screening).
6. Hemoglobin < 9.0 g/dl;
7. Immune depressed (CBC at screening);
8. White blood cell count < 3,500/mm^3;
9. Neutrophil count < 2,000/mm^3;
10. Platelet count < 125,000/mm^3;
11. Receiving immunosuppressive therapy (i.e., oral prednisone in doses > 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)