Patients who has heart failure and found to be insulin resistant (pre-diabetic state). Insulin resistance can be identified using a blood test.
Conditions
Interventions
Trade Name: Glucophage (Metformin)
Product Name: Metformin
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients aged 25-80 yrs with compensated CHF in NYHA functional I-III with evidence of insulin resistance [fasting insulin resistance index values of > 2.7 are said to have insulin resistance]. • Documented Left ventricular dysfunction and/or LV ejection fraction =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (i) elderly patients (aged >80 yrs); (ii) patients with decompensated CHF (NYHA functional class IV and /or signs of decompensated CHF); (iii) renal dysfunction (serum creatinine > 160 mmol/L); (iv) Patients who are unable to exercise including patients that will be excluded for reasons of safety or potential effects on exercise performance. Therefore, patients with angina or other cardiac or pulmonary symptoms potentially limiting exercise performance will be excluded. (v) Systolic blood pressure >190 mmHg at rest or >250 mmHg with exercise or diastolic blood pressure >95 mmHg at rest or >105 mmHg with exercise will also be a reason for exclusion; (vi) Patients with underlying disease likely to limit life span and/or increase risk of interventions will be excluded i.e., cancer; cardiovascular disease .i.e., uncontrolled hypertension: SBP>180 mmHg or DBP, recent stroke, any severe chronic disease (including renal and hepatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether Metformin will improve exercise capacity (Peak VO2) in patient with insulin resistant Chronic Heart Failure We will use an exercise re-breathing bicycle test called Innocor (from Denmark) to assess the cardiac output and hence work out the peak VO2.;Secondary Objective: If Metformin does improve exercise capacity, we would like to find out the possible mechanisms. Therefore, the following tests will be used: 1) Echo to assess pumping function 2) Flow Mediated Dilatation, Skin Laser Doppler Imaging and Endo-PaT to assess endothelial function. 3) 6 min walk test to assess exercise endurance 4) Muscle Biopsy to look at enzymes activities ;Primary end point(s): Primary end point would be peak VO2, calculated using Innocor System | — |
Countries
United Kingdom
Outcome results
None listed