''Metformin in Insulin Resistant LV Dysfunction, a double-blind, placebo-controlled trial'' - TAYSIDE Trial

Phase 1

• Conditions: Patients who has heart failure and found to be insulin resistant (pre-diabetic state).Insulin resistance can be identified using a blood test.

• Registration Number: EUCTR2007-001953-24-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-30
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 35%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified