Design and rationale for a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy (OVOID) trial: study protocol for a randomized controlled trial

The objective of this study is to compare the effects of olmesartan and valsartan on myocardial metabolism in patients with DCMP.Methods/designThe OVOID study (a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy) is designed as a non-blinded, open-label, parallel-group, prospective, randomized, controlled, multicenter clinical trial. A total of 40 DCMP patients aged between 20 and 85  years will be randomly allocated into the olmesartan or the valsartan group.18F-fluoro-2-deoxyglucose (FDG) cardiac positron emission tomography (PET) will be performed at baseline and six months after receiving the study agent. The primary endpoint is myocardial glucose consumption per square meter, measured using18F-FDG PET 6 months after receiving the study agent.DiscussionThe purpose of this trial is to compare the efficacy between olmesartan and valsartan in improving myocardial metabolism in DCMP patients. This will be the first randomized comparative study investigating the differential effects of ARBs on heart failure.Trial registrationClinicalTrials.govNCT04174456. Registered on 18 November 2019
Source: Trials - Category: Research Source Type: clinical trials