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Abstract
BackgroundPrevious studies regarding rhythm control in patients with atrial fibrillation (AF) could not sufficiently demonstrate the efficacy of available anti-arrhythmic drugs. ‘Upstream therapy’ has emerged as a potential strategy for the prevention and treatment of AF. The use of angiotensin II receptor blockers and statins has been suggested to decrease new-onset AF, but which remains inadequately explored. This study was designed to examine whether valsartan or fluvastatin can reduce the risk of non-permanent AF in patients with hypertension.Methods/designThe VF-HT-AF study is a multicenter, randomized, open-label, four-arm parallel group study with comparative evaluation of valsartan and fluvastatin as upstream therapies for the treatment of non-permanent AF complicated by hypertension. The primary outcome measure is change in the development of paroxysmal AF into persistent or permanent AF, the development of persistent AF to permanent AF, and change in incidence of overall and persistent AF recurrence, as evaluated by 7-days ambulatory electrocardiograph monitoring (Holter) and patients’ diaries during 2 years’ follow-up. Secondary outcome measures of this study include the occurrence of: (1) fatal and nonfatal myocardial infarction; (2) heart failure (New York Heart Association stage III or IV); (3) cardiogenic shock; (4) serious bleeding necessitating hospitalization; (5) malignant ventricular arrhythmia; (6) revascularization therapy; (7) radiofrequency catheter ablation of AF; (8) changes of left atrial dimension, as measured by ultrasound echocardiography; (9) stroke; (10) cardiovascular mortality; and (11) all-cause mortality. A total of 1879 patients will be investigated from 15 medical centers throughout China to obtain the relevant information.DiscussionThis is the first study in hypertensive patients complicated non-permanent AF in the Chinese population. Results of this study will inform the use of upstream therapies of AF.Trial registrationchictr.org, ChiCTR-TRC-12002642Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0836-5) contains supplementary material, which is available to authorized users.
Highlights
Previous studies regarding rhythm control in patients with atrial fibrillation (AF) could not sufficiently demonstrate the efficacy of available anti-arrhythmic drugs
The objective of the study is to test the hypothesis that upstream therapy using valsartan or fluvastatin is more effective in reducing the recurrence of AF and the progress from non-permanent AF to permanent AF in hypertensive patients with non-permanent AF, compared with conventional antihypertensive therapy using dihydropyridine calcium channel blockers (CCBs)
One consistent fact that emerges from studies is that conventional anti-arrhythmic agents, such as class I antiarrhythmics, do not improve survival rates [18], and their efficacy in preventing progression of paroxysmal AF to persistent AF is limited because they do not exert any potential benefits on electrical or structural remodeling, which contributes to the pathophysiological basis of AF [19]
Summary
Previous studies regarding rhythm control in patients with atrial fibrillation (AF) could not sufficiently demonstrate the efficacy of available anti-arrhythmic drugs. Atrial fibrillation (AF), the most common clinically significant cardiac arrhythmia, is associated with increased mortality and morbidity [1, 2], especially in hypertensive patients [3]. In the past few years, a number of trials investigating upstream therapy for the prevention of AF have been reported [9]. The renin-angiotensin system (RAS) is an important therapeutic target for atrial remodeling. Angiotensin II receptor blockers (ARBs) have recently been reported to suppress AF recurrence in both paroxysmal and persistent AF in selected patients.
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