Protocol for a randomized controlled trial of intensive blood pressure control on cardiovascular risk reduction in patients with atrial fibrillation: Rationale and design of the CRAFT trial.

Background: Co-morbid hypertension is strong predictor of adverse cardiovascular (CV) outcomes in patients with atrial fibrillation (AF) but the optimal target for blood pressure (BP) control in this patient population has not been clearly defined.
Methods: The Cardiovascular Risk reduction in patients with Atrial Fibrillation Trial (CRAFT) is an investigator-initiated and conducted, international, multicenter, open-label, parallel-group, blinded outcome assessed, randomized controlled trial of intensive BP control in patients with AF. The aim is to determine whether intensive BP control (target home systolic blood pressure [SBP] <120 mmHg) is superior to standard BP control (home SBP <135 mmHg) on the hierarchical composite outcome of time to CV death, number of stroke events, time to the first stroke, number of myocardial infarction (MI) events, time to the first MI, number of heart failure hospitalization (HFH) events, and time to the first HFH. A sample size of 1,675 patients is estimated to provide 80% power to detect a win-ratio of 1.50 for intensive versus standard BP control on the primary composite outcome. Study visits are conducted at 1, 2, 3, and 6 months postrandomization, and every 6 months thereafter during the study.
Conclusions: This clinical trial aims to provide reliable evidence of the effects of intensive BP control in patients with AF.
Trial Registration: The trial is registered at ClinicalTrials.gov (NCT04347330).
Competing Interests: Conflict of interest The principal Investigators of CRAFT study have no disclosures of financial and other competing interests. CSA reports receiving funding from the Medical Research Council (MRC) and Medical Research Foundation (MRF) of the UK, and the National Health and Medical Research (NHMRC) of Australia, and Penumbra and Takeda. AP is the nonremunerated Chair of the Board of George Medicines, a commercial spin-out of The George Institute that is aiming to bring a novel fixed-dose antihypertensive combination to market, and reports receiving funding from NHMRC.
(Copyright © 2024. Published by Elsevier Inc.)