Cardiovascular Risk Reduction in Atrial Fibrillation Trial

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Hypertension
• Interventions: Drug: Intensive BP Control; Drug: Standard BP Control

• Registration Number: NCT04347330
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. AF is associated with elevated risks of death, stroke, coronary event, heart failure, cognitive decline, and chronic kidney disease. To identify preventive interventions for major cardiovascular events beyond effective anticoagulation should be a major priority in the treatment of AF patients. The CRAFT study is a 2-arm, multicenter, randomized clinical trial designed to test whether intensive blood pressure control will reduce the risk of major cardiovascular events in AF patients.

Detailed Description

The CRAFT trial will include approximately 1675 AF patients with home SBP 125-154 mmHg and at least another cardiovascular risk factor. The trial aims to compare the effects of randomization to a treatment program of an intensive SBP goal (target home SBP \<120mmHg) with randomization to a treatment program of a standard goal (target home SBP \<135mmHg). The primary hypothesis is that cardiovascular event rates will be lower in the intensive arm. Participants will be recruited over a 4-year period at approximately 100 to 150 clinical centres and the first patient will be followed for up to 5 years.

Study Timeline

• Study First Submitted: 2020-03-29
• Study First Submitted QC: 2020-04-12
• Study First Posted: 2020-04-15
• Study Start: 2020-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1675

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive BP Control	Intensive BP Control	Participants randomized into the Intensive BP Control arm will have a goal of home SBP \<120mmHg. For most participants in the Intensive Group, a two- or three-drug regimen should be initiated at randomization. Following the randomization visit, addition of another drug or medication dose titration is indicated if home SBP is ≥120 mmHg. Monthly visits will continue in the Intensive Group until home SBP \<120 mmHg or no more titration planned. If the home SBP is not \<120 mmHg at the every 6-month visit, then an antihypertensive drug from a class different from what is being taken should be added, rather than up-titration the dosage of previous drugs, unless there are compelling reasons against this practice.
Standard BP Control	Standard BP Control	Participants randomized into the Standard BP Control arm will have a goal of home SBP \<135mmHg. The Standard BP protocol is designed to achieve a home SBP of 130-134 mmHg in as many participants as possible. Following the randomization visit, medication dose titration or addition of another drug is indicated if home SBP ≥135 mmHg. Monthly visits will continue in the Standard Group when home SBP ≥155 mmHg. Down titration (a reduction of the dose or number of antihypertensive drugs) should be carried out if the home SBP is \<125 mmHg.

Primary Outcome Measures

Name	Time	Method
Hierarchical composite cardiovascular outcomes	5 years	a hierarchical composite of cardiovascular death, number of strokes, time to first stroke, number of MI, time to first MI, number of HF, and time to first HF

Secondary Outcome Measures

Name	Time	Method
Main secondary cardiovascular outcomes	5 years	Time to the first occurrence of the components of the primary outcome: cardiovascular Death, stroke, myocardial infarction, hospitalization for heart failure.
Main secondary renal outcomes	5 years	Time to the first occurrence of chronic kidney disease progression or incident albuminuria.
All-cause mortality	5 years	Time to all deaths.
Change of the concern of falling	5 years	Change of the concern of falling (measured by the Short Fall Self-Efficacy Scale International) from baseline to the end of the study.
Change of the health state utility	5 years	Change of the health state utility (measured by the EuroQoL Group 5-Dimension Self-Report questionnaire from baseline to the end of the study.
Change of the self-report depression	5 years	Change of the depression (measured by the Patient Health Questionnaire-9) from baseline to the end of the study.
Change of the self-report anxiety	5 years	Change of the anxiety (measured by the Zung Self-rating Anxiety Scale) from baseline to the end of the study.
Change of the frailty	5 years	Change of the frailty (measured by the 5-item FRAIL scale) from baseline to the end of the study.

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China