- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03331861
Metformin in Heart Failure Without Diabetes (Met-HeFT)
Columbia University Medical Center is conducting a pilot clinical research study that will assess the use of the medication metformin for heart failure in patients who are not diabetic and have no evidence of insulin resistance.
Patients will received either the study drug metformin or placebo for 4 months. During the study, the patients will undergo extensive testing that will include symptom assesment, exercise capacity, echocardiography, cardiac PET imaging and blood tests.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Barry Fine, MD
- Telefonnummer: 212-305-5755
- E-post: bmf2002@cumc.columbia.edu
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10032
- Rekruttering
- New York Hospital - Columbia University Irving Medical Center
-
Ta kontakt med:
- Andrea Kim
- Telefonnummer: 212-305-1368
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients with chronic heart failure (defined as >6 months duration) uptitrated to recommended or maximally tolerated dose of ACE-I/ARB (unless contraindicated) and beta-blocker (unless contraindicated). If indicated, an aldosterone receptor antagonist should be given (unless contraindicated). An ICD and/or CRT-D should be implanted, if indicated. Patients with a CRT device should be treated for > 3 months.
- Reduced ejection fraction defined as LVEF < 40%
- NYHA-class II or III with stable symptoms for at least the past 3 months
- Renal Function by eGFR > 45 ml/min (MDRD equation) in accordance with FDA guidance on metformin use in CKD
- Ability to understand the written patient information and to give informed consent
- Negative urine-HCG for women of childbearing potential
Exclusion Criteria:
Patients with diabetes or insulin resistant, defined as 1 or more of the following criteria:
- HbA1c >6.0% within the last 12 months prior to enrollment
- Impaired fasting insulin resistance index (HOMA-IR) >2.7
- Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)
- Recent Hospitalizations in the past 3 months
- Metformin treatment within the last 3 months
- eGFR below 45 in the prior 6 months
- Known allergy to metformin or major side effects to metformin treatment
- Acute myocardial infarction, unstable angina or revascularization < 3 months at the time of randomization
- Planned coronary revascularization, heart surgery, CRT implantation or other intervention during the study period that would potentially affect the function of the heart
- Significant, uncorrected cardiac valve disease
- Cardiac arrest or life threatening ventricular arrhythmias within the last 3 months (unless treated with an ICD)
- Atrial fibrillation with poorly controlled ventricular rate at rest (> 100 beats/min)
- Hypertrophic or restrictive cardiomyopathy, infiltrative or storage myocardial disease, active myocarditis, or pericardial disease.
- Planned major surgery
- Female patients who are pregnant, nursing, or of childbearing potential while not practicing effective chemical contraceptive methods (i.e. oral, implanted, injectable, or transdermal contraceptive hormones; intrauterine device)
- Current abuse of alcohol or drugs
- Life-expectancy of less than 1 year due to co-existing morbid illness
- Stroke within the last 6 months
- Liver disease with P-ALAT >3 times upper normal limit (it is possible to repeat this measurement once within a month)
- Significant comorbidity or issue that makes the patient unsuitable for participation as judged by the investigator
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Metformin
Metformin for 6 months
|
Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months
|
Placebo komparator: Placebo
Matched placebo for 6 months
|
Similar dosing regime as active comparator
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Minute Ventilation to Carbon Dioxide Production (VE/VCO2) Slope
Tidsramme: Baseline and 6 months
|
Baseline and 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Dyspnea Assesment Score
Tidsramme: Baseline and 6 months
|
100mm Visual Analog Scale.
100mm line scale ranging from 0 (worse imaginable breathing) to 100 (best imaginable breathing)
|
Baseline and 6 months
|
Minnesota Health Living with Heart Failure Questionnaire
Tidsramme: Baseline and 6 months
|
Score
|
Baseline and 6 months
|
Left Ventricular Function Evaluated by Ejection Fraction and Diastolic Function on Echocardiography
Tidsramme: Baseline and 6 months
|
Baseline and 6 months
|
|
Global Longitudinal Strain and Strain Rate Measured on Echocardiography
Tidsramme: Baseline and 6 months
|
Baseline and 6 months
|
|
B Type Natriuretic Peptide (BNP) level
Tidsramme: Baseline and 6 months
|
Baseline and 6 months
|
|
Body Weight
Tidsramme: Baseline and 6 months
|
kg
|
Baseline and 6 months
|
Peak Myocardial Oxygen Consumption (VO2)
Tidsramme: Baseline and 6 months
|
Baseline and 6 months
|
|
Quantitative 18F-FDG Activity in 9 Myocardial Segments
Tidsramme: Baseline and 6 months
|
Glucose Metabolism
|
Baseline and 6 months
|
Quantitative N13-NH3 Activity in 9 Myocardial Segments
Tidsramme: Baseline and 6 months
|
Perfusion
|
Baseline and 6 months
|
Heart Failure Hospitalizations
Tidsramme: Over 6 months
|
number
|
Over 6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Hemoglobin A1c
Tidsramme: Baseline and 6 months
|
Baseline and 6 months
|
|
Serum Lactate
Tidsramme: 1 month and 6 months
|
1 month and 6 months
|
|
Fasting Sugar
Tidsramme: 1 month and 6 months
|
mg/dl
|
1 month and 6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Barry Fine, MD, Columbia University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AAAR5389
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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