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The cardiac MRI substudy to ongoing telmisartan alone and in combination with ramipril global endpoint trial/telmisartan randomized assessment study in ACE-intolerant subjects with cardiovascular disease: analysis protocol and baseline characteristics

Citation

Cowan, BR and Young, AA and Anderson, C and Doughty, RN and Krittayaphong, R and Lonn, E and Marwick, TH and Reid, CM and Sanderson, JE and Schmieder, RE and Teo, K and Wadham, AK and Worthley, SG and Yu, C-M and Yusuf, S and Jennings, GL, The cardiac MRI substudy to ongoing telmisartan alone and in combination with ramipril global endpoint trial/telmisartan randomized assessment study in ACE-intolerant subjects with cardiovascular disease: analysis protocol and baseline characteristics, Clinical Research in Cardiology, 98, (7) pp. 421-433. ISSN 1861-0684 (2009) [Refereed Article]

Copyright Statement

Copyright 2009 Springer Verlag

DOI: doi:10.1007/s00392-009-0014-4

Abstract

Background The ONTARGET and TRANSCEND clinical trials were designed to investigate the cardioprotective effects of telmisartan 80 mg and ramipril 10 mg, alone and in combination, in patients at high risk of cardiovascular disease. Cardiac MRI enables investigation of mechanistic effects of these agents on cardiac structural and functional variables. Here, we report the design, analysis protocol, reproducibility and relevant quality control procedures, and baseline patient characteristics of the ONTARGET/ TRANSCEND cardiac MRI substudy. MRI was undertaken in 330 subjects enrolled in ONTARGET, and 38 subjects in TRANSCEND, across eight centers in six countries. Analyses were performed by two independent analysts using guide-point modeling. Cases with discrepancies in LV mass (LVM) of >5% were independently reanalyzed. Cases with discrepancies in end-diastolic volume (EDV) of >5%, or end-systolic volume (ESV) of >12%, were then reconciled by consensus.
Results Baseline characteristics were broadly similar to the main ONTARGET/TRANSCEND trials, except for a higher frequency of coronary artery disease and Asian ethnicity in the substudy. Reproducibility of MRI analyses (mean SD) were 2.8 3.7 ml in EDV,-0.3 3.6 ml in ESV, 3.1 3.3 ml in SV, 1.1 1.8% in EF, and 0.4 4.5 g in LVM. Subgroup analyses revealed increased ESV and LVM, and reduced EF, in subjects with a history of either coronary artery disease or myocardial infarction.
Conclusions The ONTARGET/TRANSCEND cardiac MRI substudy protocol provides for a reliable assessment of the effects of telmisartan and ramipril, alone and in combination, on cardiac structural and functional parameters over a 2-year follow-up period.

Item Details

Item Type:Refereed Article
Research Division:Medical and Health Sciences
Research Group:Cardiorespiratory Medicine and Haematology
Research Field:Cardiology (incl. Cardiovascular Diseases)
Objective Division:Health
Objective Group:Clinical Health (Organs, Diseases and Abnormal Conditions)
Objective Field:Cardiovascular System and Diseases
Author:Marwick, TH (Professor Tom Marwick)
ID Code:90770
Year Published:2009
Web of Science® Times Cited:9
Deposited By:Menzies Institute for Medical Research
Deposited On:2014-04-23
Last Modified:2014-05-22
Downloads:0

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