Atrial FibrillationCRAFTNCT04347330
Cardiovascular Risk Reduction in Atrial Fibrillation Trial
A study of Atrial Fibrillation and Hypertension, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,675 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- An indication for a specific BP lowering medication (e.g., beta-blocker following acute myocardial infarction) that the person is not taking, without evidence of intolerance. The screenee should be on the appropriate dose of such medication before assessing whether he/she meets the CRAFT inclusion criteria.
- Known secondary cause of hypertension that causes concern regarding safety of the protocol.
Show all 20Show fewer
- 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.
- Living in the same household as an already randomized CRAFT participant
- Any organ transplant
- Unintentional weight loss > 10% in last 6 months
- Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing
Xin Du, MD, PhD
Chao Jiang, MD
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Hypertension
- Being tested
- Intensive BP Control, Standard BP Control
- Keywords
- Intensive blood pressure control, Cardiovascular events
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive BP ControlDrug
Also called Control of home SBP to a target of 120mmHg
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.
Standard BP ControlDrug
Also called Control of home SBP to a target of 135mmHg
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard BP Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (8)
All-cause mortality
Time to all deaths.
Measured: 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.
Measured: 5 years
Main secondary renal outcomes
Time to the first occurrence of chronic kidney disease progression or incident albuminuria.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start31 Aug 2020
- Primary completionJun 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Health Research Center, The George Institute for Global Health, China, The George Institute for Global Health, Australia, Fukuoka University
- Responsible party
- Principal investigator, Chang sheng Ma, Beijing Anzhen Hospital
- Investigators
- Changsheng Ma, Doctor, Principal investigator, Beijing Anzhen HospitalCraig S Anderson, Doctor, Principal investigator, The George Institute for Global Health, China; Heart Health Research CentreJianzeng Dong, Doctor, Principal investigator, Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347330
- Sponsor's protocol ID
- 2020-005
- Acronym
- CRAFT
- Status last verified
- Dec 2023
- First submitted
- 29 Mar 2020
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39182902
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Reduction in Atrial Fibrillation Trial
- ClinicalTrials.gov ID
- NCT04347330
- Acronym / sponsor ID
- CRAFT / 2020-005
- Conditions
- Atrial Fibrillation, Hypertension
- Keywords
- Intensive blood pressure control, Cardiovascular events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,675 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Heart Health Research Center, The George Institute for Global Health, China, The George Institute for Global Health, Australia, Fukuoka University
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive BP Control | Experimental | Drug: Intensive BP ControlParticipants 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 | Active comparator | Drug: Standard BP ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
- An indication for a specific BP lowering medication (e.g., beta-blocker following acute myocardial infarction) that the person is not taking, without evidence of intolerance. The screenee should be on the appropriate dose of such medication before assessing whether he/she meets the CRAFT inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive BP ControlAlso: Control of home SBP to a target of 120mmHgParticipants 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. | Drug | Intensive BP Control |
| Standard BP ControlAlso: Control of home SBP to a target of 135mmHgParticipants 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. | Drug | Standard BP Control |
Primary outcome
Hierarchical composite cardiovascular outcomes
Time frame: 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
8 secondary outcomes
All-cause mortality
Time frame: 5 years
Main secondary cardiovascular outcomes
Time frame: 5 years
Main secondary renal outcomes
Time frame: 5 years
Change of the health state utility
Time frame: 5 years
Change of the self-report depression
Time frame: 5 years
Change of the self-report anxiety
Time frame: 5 years
Change of the concern of falling
Time frame: 5 years
Change of the frailty
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 39182902Jiang 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changsheng Ma, Doctor principal investigator
Beijing Anzhen Hospital
Craig S Anderson, Doctor principal investigator
The George Institute for Global Health, China; Heart Health Research Centre
Jianzeng Dong, Doctor principal investigator
Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Atrial Fibrillation and Hypertension, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Du, Doctor (86-10-64420102, duxinheart@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite cardiovascular outcomes (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.