Effect of Metformin and Empaglifozin in insulin resistant patients with heart failure with reduced ejection fractio
- Conditions
- I50Heart Failure with reduced ejection fraction (HFrEF) and insulin resistanceHeart failure
- Registration Number
- DRKS00013928
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
1. Signed Written Informed Consent
2. Age =18 years,
3. Patients with clinical signs of heart failure (NYHA II-III) in stable ambulatory condition,
4. Patients with the diagnosis of HFrEF for >6 months,
5. Left ventricular ejection fraction (LVEF) =50%,
6. 6-minute walking distance of <450m,
7. Elevated natriuretic peptides (BNP =100pg/mL or N-terminal-pro-BNP =300 pg/mL),
8. Current standard medication for HFrEF therapy according to guideline recommendations in individually optimized doses,
9. Patients need to be free of signs of acute decompensated HF, but can be recruited at the end of a hospital stay, if clinically stabilised,
10. Presence of insulin resistance (HOMA-IR >2.0; Spise index <6.87; Quicky index < 0.32)
11. Willing and capable of providing informed consent, participating in all associated study activities
1. Acute decompensation of HF or acute dehydration,
2. current treatment with metformin
3. known hypersensitivity or contraindication for Metformin or to any of the excipients of the Investigational Medicinal Product (IMP) or placebo
4. Type I DM
5. Diagnosed DM (HbA1c > 7.0 or existing medical treatment for DM)
6. Clinical signs or symptoms of dehydration requiring iv volume therapy,
7. impaired kidney function > CKD stage III (GFR < 30 ml/min/1.73m2)
8. Acute infection requiring antibiotic therapy
9. Any clinical condition that limits the life expectancy < 1 year
10. incapability to participate in the trial
11. Acute systemic illness, malignancy, inflammatory disease, requiring, antibiotic therapy, immune-suppressive - or steroid therapy
12. Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial
13. Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial
14. Subjects who are legally detained in an official institution
15. Subjects who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
17. For female patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index < 1) throughout the study period
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in global longitudinal strain (GLS) of the left ventral (LV) after 24 weeks therapy. Primary endpoint assessed by single-centre Cardio MR and echocardiographie.
- Secondary Outcome Measures
Name Time Method At 24 and 52 weeks:<br>• Change in 6 min walking distance <br>• Patient global assessment (PGA, Questionnaire)<br>• Change in NYHA functional class<br>• Change in Quality of life assessed by EQ5-D and Kansas City Cardiomyopathy Questionnaire (KCCQ)<br>• Change in plasma levels of brain-type natriuretic peptides (BNP)<br>