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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,675
Participants in the Intensive group have a goal of home SBP \<120 mm Hg. The CRAFT BP treatment protocol is flexible in terms of the choice and doses of antihypertensive medications, but there should be preferences among the drug classes, based on CVD outcome trials results and current guidelines. Use of once-daily antihypertensive agents will be encouraged unless alternative frequency is indicated/necessary. Combination of different classes of agents are encouraged to achieve the home SBP goal. Medications will not be provided by the CRAFT study.
Participants in the Standard group has a goal of home SBP \<135 mmHg. The same principle of BP treatment in the Intensive BP arm will be used for the Standard BP arm. Medications will not be provided by the CRAFT study.
Beijing Anzhen Hospital
Beijing, China
RECRUITINGHierarchical composite cardiovascular outcomes
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
Time frame: 5 years
All-cause mortality
Time to all deaths.
Time frame: 5 years
Main secondary cardiovascular outcomes
Time to the first occurrence of the components of the primary outcome: cardiovascular Death, stroke, myocardial infarction, hospitalization for heart failure.
Time frame: 5 years
Main secondary renal outcomes
Time to the first occurrence of chronic kidney disease progression or incident albuminuria.
Time frame: 5 years
Change of the health state utility
Change of the health state utility (measured by the EuroQoL Group 5-Dimension Self-Report questionnaire from baseline to the end of the study.
Time frame: 5 years
Change of the self-report depression
Change of the depression (measured by the Patient Health Questionnaire-9) from baseline to the end of the study.
Time frame: 5 years
Change of the self-report anxiety
Change of the anxiety (measured by the Zung Self-rating Anxiety Scale) from baseline to the end of the study.
Time frame: 5 years
Change of the concern of falling
Change of the concern of falling (measured by the Short Fall Self-Efficacy Scale International) from baseline to the end of the study.
Time frame: 5 years
Change of the frailty
Change of the frailty (measured by the 5-item FRAIL scale) from baseline to the end of the study.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.