Trial document




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  DRKS00013928

Trial Description

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Title

Effect of Metformin in insulin resistant patients with heart failure with reduced ejection fraction

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Trial Acronym

METRIS-HF-DZHK18

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URL of the Trial

https://metris-hf.dzhk.de/

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Brief Summary in Lay Language

Heart failure is characterised by a weakened heart muscle that can no longer develop its normal muscle strength. Due to a worsened energy metabolism of muscle cells, the body is unable to utilize the energy of the food optimally, which reduces the performance of the muscle cells and thus the performance of the entire body. Metformin is a well-known drug that improves energy metabolism and normalizes it to a large extent. Therefore, the aim of the METIS-HF-DZHK18 is to investigate whether the use of metformin in patients with heart failure leads to better cardiac output and reduces the symptoms of the disease.

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Brief Summary in Scientific Language

Analysis and clinical investigation of metformin combined with standard therapy on improvement of myocardial contractility and function in insulin-resistant HFrEF patients.

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Organizational Data

  •   DRKS00013928
  •   2018/07/30
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  •   yes
  •   Approved
  •   18/0101 - ZS EK13, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   2017-004149-26 
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Health Condition or Problem studied

  •   Heart Failure with reduced ejection fraction (HFrEF) and insulin resistance
  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Metformin, 2x1000 mg/d p.o. for 24 weeks, on top of standard care according to international guidelines for the treatment of heart failure
  •   matching Placebo on top of standard care
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   No
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Primary Outcome

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.

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Secondary Outcome

At 24 and 52 weeks:
• Change in 6 min walking distance
• Patient global assessment (PGA, Questionnaire)
• Change in NYHA functional class
• Change in Quality of life assessed by EQ5-D and Kansas City Cardiomyopathy Questionnaire (KCCQ)
• Change in plasma levels of brain-type natriuretic peptides (BNP)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/10/08
  •   88
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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

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Exclusion Criteria

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



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Addresses

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    • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
    • 13316  Berlin
    • Germany
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    • Universitätsmedizin GöttingenGeorg-August-UniversitätInstitut für Medizinische Informatik
    • Mr. 
    • Von-Siebold-Str. 3
    • 37075  Göttingen
    • Germany
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    • unabhängige Treuhandstelle der Universitätsmedizin Greifswald K.d.ö.R
    • Mr. 
    • Ellernholzstr. 1-2
    • 17487  Greifswald
    • Germany
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    • Deutsches HerzzentrumKlinik für Kardiologie
    • Mr.  Prof. Dr.  Sebastian  Kelle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinCampus BuchExperimental Clinical Research Center
    • Ms.  Prof. Dr.  Jeanette  Schulz-Menger 
    • Lindenberger Weg 80
    • 13125  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinCampus BuchExperimental and Clinical Research Center (ECRC)
    • Mr.  Prof. Dr.  Dominik  Müller 
    • Lindenberger Weg 80
    • 13125  Berlin
    • Germany
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    • Universitätsmedizin GöttingenInstitut für Medizinische Statistik
    • Mr.  Tim  Friede 
    • Humboldtallee 32
    • 37073  Göttingen
    • Germany
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    • Charité - Universitätsmedizin BerlinCampus BuchExperimental and Clinical Research Center (ECRC)
    • Mr.  Dr.  Michael  Boschmann 
    • Lindenberger Weg 80
    • 13125  Berlin
    • Germany
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    • Center for Stroke Research Berlin - CSB And Department of Cardiology, Campus Virchow Klinikum
    • Mr.  Prof. Dr. Dr.  Wolfram  Döhner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universtitätmedizin Berlin
    • Ms.  Kathleen   Weigt 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • BMBF über Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
    • 13316  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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