Renal sympathetic denervation versus antiarrhythmic drugs for drug-resistant hypertension and symptomatic atrial fibrillation (RSDforAF) trial: study protocol for a randomized controlled trial

Min Qiu, Yuehui Yin, Qijun Shan, Min Qiu, Yuehui Yin, Qijun Shan

Abstract

Background: Recently, catheter-based renal sympathetic denervation (RSD) has been verified to be safely used to substantially reduce the levels of blood pressure, left ventricular hypertrophy, sleep apnea severity and norepinephrine spillover, and improve glucose tolerance. All these pathological changes are recognized as independent risk factors for the development and recurrence of atrial fibrillation (AF). A randomized, single-blind, parallel-control, multicenter clinical trial is being conducted to compare RSD with antiarrhythmic drugs (AAD) in patients with drug-resistant hypertension and symptomatic AF (RSDforAF trial).

Methods/design: Patients with drug-resistant hypertension and symptomatic AF will be randomized to RSD and the drug treatment groups. Patients will be followed for 12 months until study closure. Up to 200 patients may be enrolled in six medical centers in China. The primary objective is to study the effects of RSD on AF burden and blood pressure in patients with hypertension and symptomatic AF.

Discussion: RSDforAF trial will test the hypothesis that RSD is superior to AAD in reducing AF burden and blood pressure in patients with drug-resistant hypertension and symptomatic AF.

Trial registration: ClinicalTrials.gov, NCT01713270.

Figures

Figure 1
Figure 1
The enrollment cascade and follow-up procedure. AAD, Antiarrthymic drugs; ABPM, Ambulatory blood pressure monitoring; AF, Atrial fibrillation; AHI, Apnea-hypopnea index; CT, Computed tomography; ECG, Electrocardiogram; Holter; ambulatory cardiogram; PWV, Pulse wave velocity; RSD, Renal sympathetic denervation; SF-36, Short Form-36 quality-of-life questionnaire.

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