The effect of rosiglitazone on integrated cardiovascular performance, cardiac structure, function and myocardial triglyceride: trial design and rationale

Author:

Mcguire Darren K1,See Raphael2,Abdullah Shuaib M1,Snell Peter G1,Mcgavock Jonathan M1,Ayers Colby R3,Szczepaniak Lidia S1

Affiliation:

1. Department of Internal Medicine, the University of Texas Southwestern Medical Center, Dallas, Texas, US.

2. Division of Cardiology, Vanderbilt University, Nashville, Tennessee, 37240, US.

3. Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, US.

Abstract

The thiazolidinedione (TZD) class of medications has been associated with increased risk for peripheral oedema, as well as incident and worsening heart failure (HF). The mechanism of these observed effects remains unclear. Here we present the rationale and study design for a randomised clinical trial designed to evaluate the cardiac effects of rosiglitazone on integrated cardiovascular performance, cardiac structure and function. The study is a randomised, single-centre, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the effect of rosiglitazone on integrated cardiovascular performance in a cohort of patients with type 2 diabetes mellitus (T2DM) at increased risk for developing heart failure (HF). Participants will be randomised to receive rosiglitazone or matching placebo for six months. All subjects will undergo maximal treadmill cardiopulmonary exercise testing at baseline and after six months on study drug, with the primary trial end point of peak oxygen uptake indexed to fat-free mass (VO2peak-FFM). Approximately two-thirds of the study cohort will undergo cardiac magnetic resonance imaging (MRI) and spectroscopy (MRS) at baseline and after six months of study therapy to assess cardiac structure, function and myocardial triglyceride content. While concerns for peripheral oedema and HF continue to confound clinical use of TZD medications, the direct cardiac effects of these drugs remain poorly understood and the clinical relevance of these clinical observations remains unclear. The present study will combine a series of state-of-the-art assessments to evaluate the cardiac effects of rosiglitazone treatment. (ClinicalTrials.gov NCT00424762).

Publisher

SAGE Publications

Subject

Cardiology and Cardiovascular Medicine,Endocrinology, Diabetes and Metabolism,Internal Medicine

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