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
| Autor: | Sua Jo, Hyeyeon Moon, Kyungil Park, Chang-Bae Sohn, Jeonghwan Kim, Yong-Seop Kwon, Su Hong Kim |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Aged 80 and over Cardiomyopathy Dilated Medicine (General) Positron emission tomography Imidazoles Medicine (miscellaneous) Tetrazoles Angiotensin-Converting Enzyme Inhibitors Middle Aged Myocardial metabolism Angiotensin Receptor Antagonists Young Adult Study Protocol R5-920 Treatment Outcome Humans Multicenter Studies as Topic Valsartan Olmesartan Pharmacology (medical) Prospective Studies Aged Randomized Controlled Trials as Topic |
| Zdroj: | Trials Trials, Vol 23, Iss 1, Pp 1-9 (2022) |
| ISSN: | 1745-6215 |
| Popis: | Background Dilated cardiomyopathy (DCMP) is characterized by ventricular chamber enlargement and systolic dysfunction which may cause heart failure. Patients with DCMP have overactivation of the renin-angiotensin-aldosterone systems, which can also adversely affect myocardial metabolism in heart failure. The impairment of myocardial metabolism can contribute to the progression of left ventricular remodeling and contractile dysfunction in heart failure. Although angiotensin II receptor blockers (ARBs) have been used to treat patients with DCMP, there has been no direct comparison of the efficacy of these agents. The objective of this study is to compare the effects of olmesartan and valsartan on myocardial metabolism in patients with DCMP. Methods/design The 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 using 18F-FDG PET 6 months after receiving the study agent. Discussion The 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 registration ClinicalTrials.govNCT04174456. Registered on 18 November 2019 |
| Databáze: | OpenAIRE |
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