Phase 4 N=62 Randomized Double-blind Treatment

Metformin in Insulin Resistant Left Ventricular (LV) Dysfunction (TAYSIDE Trial)

Congestive Heart Failure · Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT00473876 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Jun 2013

Primary outcome: Primary: Peak VO2 — -0.38; 3.6 ml/kg/min — p=0.08

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Metformin (Drug); Matched Placebo (Capsules) (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: University of Dundee
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak VO2	-0.38; 3.6	0.08
SECONDARY Possible Mechanisms That Can Explain the Improvement of Exercise Capacity	-4.45; -0.23	0.034 sig

Summary

Will metformin improve exercise capacity in chronic heart failure patients who has insulin resistance (pre-diabetic- means before they become diabetic)?

Eligibility 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 systolic dysfunction or LV ejection fraction 80 yrs);
Patients with decompensated CHF (NYHA functional class IV and /or signs of decompensated CHF);
Renal dysfunction (serum creatinine > 160 mmol/L);
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.
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;
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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00473876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.