Cardiovascular Risk Reduction in Atrial Fibrillation Trial

NCT04347330 | Unknown DMC

• 1 other identifier: 2020-005
• Study Type: interventional
• Target: 1,675
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Hypertension

Keywords

Intensive blood pressure control; Cardiovascular events

Outcome Measures

Primary Outcomes (1)

• Hierarchical 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

  5 years

Secondary Outcomes (8)

• All-cause mortality

  5 years

• Main secondary cardiovascular outcomes

  5 years

• Main secondary renal outcomes

  5 years

• Change of the health state utility

  5 years

• Change of the self-report depression

  5 years

Other Outcomes (3)

• Major bleeding

  5 years

• Peripheral arterial disease

  5 years

• Coronary revascularization

  5 years

Study Arms (2)

Intensive BP Control

EXPERIMENTAL

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.

Drug: Intensive BP Control

Standard BP Control

ACTIVE COMPARATOR

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.

Drug: Standard BP Control

Interventions

Intensive BP Control DRUG

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.

Also known as: Control of home SBP to a target of 120mmHg

Intensive BP Control

Standard BP Control DRUG

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.

Also known as: Control of home SBP to a target of 135mmHg

Standard BP Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, ≥18 years old
• Documented AF: persistent atrial fibrillation or at least two episodes of intermittent atrial fibrillation in the previous 6 months.
• Home SBP 125-154 mmHg, defined as average of all SBP readings (at least 3 readings 1 min apart in the morning before taking antihypertensive drugs and evening before going to sleep) during the run-in assessment.
• One or more cardiovascular risk factors: (1) Prior history of thromboembolism: defined as any of the following criteria: a) ischemic stroke; b) transient ischemic attack (TIA); c) systemic embolism (SE); (2) Diabetes mellitus (DM): defined as any of the following criteria: a) use of oral hypoglycemic drugs or insulin; b) random blood glucose values ≥11.1 mmol/L in the presence of classic symptoms of hyperglycemia; c) fasting plasma glucose values ≥7.0 mmol/L; d) two-hour plasma glucose values ≥11.1 mmol/L during an oral glucose tolerance test; e) HbA1C values ≥6.5%; (3) Coronary artery disease or Peripheral artery disease: defined as any of the following criteria: a) Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy (CE), carotid stenting; b) Peripheral artery disease (PAD) with revascularization; c) Acute coronary syndrome with or without resting ECG change, ECG changes on a graded exercise test, or positive cardiac imaging study; d) At least a 50% diameter stenosis of a coronary, carotid, or lower extremity artery; e) Abdominal aortic aneurysm ≥5 cm with or without repair; (4) Chronic kidney disease (CKD): defined as estimated glomerular filtration rate (eGFR) 30-59ml/min/1.73m2 based on the latest lab value within the past 6 months; (5) Age ≥65 years old

You may not qualify if:

• Successful AF ablation (no documented recurrence of AF, atrial flutter, or atrial tachycardia lasting \>30s)
• Moderate-to-severe mitral stenosis, or mechanical heart valve replacement
• Home SBP ≥145 mmHg while already taking ≥4 full dose BP lowering agents, indicating resistant hypertension or poor adherence.
• Unable to upload home BP readings for at least 5 days during the run-in assessment.
• Known secondary cause of hypertension that causes concern regarding safety of the protocol.
• One minute standing SBP \< 110 mm Hg. Not applicable if unable to stand due to wheelchair use.
• Diagnosis of polycystic kidney disease
• Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
• eGFR \<30 mL/min/1.73m2 or end-stage renal disease (ESRD)
• Cardiovascular event or procedure (as defined above as Coronary artery disease or Peripheral artery disease for study entry) or hospitalization for unstable angina within last 3 months
• Heart failure with reduced left ventricular ejection fraction (\< 40%), or New York Heart Association Class III-IV
• Individuals who have been previously diagnosed with dementia by their physicians
• A medical condition likely to limit survival to less than 3 years, or a cancer diagnosed and treated within the past two years that, in the judgment of clinical study staff, would compromise a participant's ability to comply with the protocol and complete the trial.
• Any factors judged by the investigator to be likely to limit adherence to interventions. For example, active alcohol or substance abuse, significant memory or behavioural disorder.
• Currently participating in another clinical trial (intervention study). Note: Patient must wait until the completion of his/her activities or the completion of the other trial before being screened for CRAFT.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Heart Health Research Center: collaborator
• The George Institute for Global Health, China: collaborator
• The George Institute for Global Health, Australia: collaborator
• Fukuoka University: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Jiang C, Wang Z, Du X, Wang Y, Gao M, Jia Z, Chai Z, Yang Z, Wang C, He L, Hu R, Lv Q, Wu J, Li X, Jia C, Han R, Arima H, Wang X, Neal B, Rodgers A, Hillis GS, Patel A, Li Q, Dong J, Anderson CS, Ma C. 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. Am Heart J. 2024 Dec;278:33-40. doi: 10.1016/j.ahj.2024.08.008. Epub 2024 Sep 7.

  PMID: 39182902 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Changsheng Ma, Doctor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Craig S Anderson, Doctor

  The George Institute for Global Health, China; Heart Health Research Centre

  PRINCIPAL INVESTIGATOR

• Jianzeng Dong, Doctor

  Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Du, Doctor

CONTACT

86-10-64420102; duxinheart@sina.com

Chao Jiang, Doctor

CONTACT

86-10-84005361; superj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 15, 2020
• Study Start: August 31, 2020
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)