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

Darren K. McGuire, Raphael See, Shuaib M. Abdullah, Peter G. Snell, Jonathan M. McGavock, Colby R. Ayers, Lidia S. Szczepaniak

Research output: Contribution to journalArticle

11 Citations (Scopus)

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 NO2peak-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 structue, 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.

Original languageEnglish (US)
Pages (from-to)43-50
Number of pages8
JournalDiabetes and Vascular Disease Research
Volume6
Issue number1
DOIs
StatePublished - Jan 2009

Fingerprint

rosiglitazone
Triglycerides
Heart Failure
Edema
Placebos
Pharmaceutical Preparations
Type 2 Diabetes Mellitus
Cohort Studies
Magnetic Resonance Spectroscopy
Randomized Controlled Trials
Fats
Magnetic Resonance Imaging
Clinical Trials
Exercise
Oxygen
Therapeutics

Keywords

  • Aaerobic power
  • Heart failure
  • Myocardial triglyceride
  • Rosiglitazone
  • Thiazolidinedione

ASJC Scopus subject areas

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

Cite this

The effect of rosiglitazone on integrated cardiovascular performance, cardiac structure, function and myocardial triglyceride : Trial design and rationale. / McGuire, Darren K.; See, Raphael; Abdullah, Shuaib M.; Snell, Peter G.; McGavock, Jonathan M.; Ayers, Colby R.; Szczepaniak, Lidia S.

In: Diabetes and Vascular Disease Research, Vol. 6, No. 1, 01.2009, p. 43-50.

Research output: Contribution to journalArticle

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