Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression (DANWRAP)
The Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression
Obesity is an important risk factor for the development and progression of atrial fibrillation. Sustainable weight loss likely reduces the burden of atrial fibrillation, which has yet to be proven in adequately sized randomised trials.
In a national, multicentre randomised trial we will test, whether a sustainable weight loss of more than 10% reduces atrial fibrillation progression and burden in patients with symptomatic paroxysmal or early persistent atrial fibrillation and a body mass index ≥27 kg/m2. A total of 480 patients will be randomised in a 1:1 fashion to either a comprehensive weight loss programme of behavioural support, meal replacement and/or pharmacotherapy with a glucagon-like peptide-1 receptor agonist on top of standard care aiming at more than 10% weight loss or standard care alone. Standard care will include guideline-directed anticoagulant therapy for stroke prevention, rate and/or rhythm control treatment, and management of risk factors and underlying cardiovascular conditions. Patients in the standard care group will receive information on weight management, but no active treatment for weight loss. Patients will be enrolled during a period of two and a half years and will be followed for one year with an equal number of study visits in both study arms. All patients will receive a 14-day continuous electrocardiographic monitoring at baseline, four, eight, and 12 months.
The study endpoints will be assessed after a 4-months blanking period from month four to 12 to allow for weight loss. The primary endpoint will be a hierarchical composite of atrial fibrillation progression, symptom burden, and treatment escalation. Secondary endpoints will be a change in weight, total atrial fibrillation burden, quality of life, and metabolic and cardiovascular biomarkers from baseline to 12 months. Safety endpoints will be adverse events related to treatment with glucagon-like peptide-1 receptor agonists and weight loss. Endpoint adjudication will be blinded.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Axel Brandes, M.D.
- 전화번호: +4579184491
- 이메일: Axel.Brandes@rsyd.dk
연구 연락처 백업
- 이름: Eva Prescott, PhD
- 이메일: eva.irene.bossano.prescott@regionh.dk
연구 장소
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-
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Copenhagen, 덴마크
- University Hospital Bispebjerg and Frederiksberg
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연락하다:
- Eva Prescott, PhD
- 이메일: eva.irene.bossano.prescott@regionh.dk
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Esbjerg, 덴마크, 6700
- Esbjerg Hospital - University Hospital of Southern Denmark
-
연락하다:
- Axel Brandes, M.D.
- 전화번호: +4579184491
- 이메일: Axel.Brandes@rsyd.dk
-
수석 연구원:
- Axel Brandes, M.D.
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion criteria:
- Symptomatic paroxysmal* or persistent** AF
- Sinus rhythm at inclusion (Visit 1)
- BMI ≥27 kg/m2
- Age>18 years
At least one 12-lead ECG or other single- or multiple-lead ECG device (e.g. Holter monitor-ing or ECG-providing wearables) documented episode during 6 months prior to inclusion
* Paroxysmal AF in this trial is defined as at least 2 episodes, either self-terminating or cardioverted within 7 days, during 6 months prior to in-clusion
**Persistent AF in this study is defined as the following:
- Duration of an AF episode >7 days and < 6 months
- Total documented AF history < 5 years
Exclusion criteria:
- Atrial flutter as the primary arrhythmia. (Patients with previous or isolated episodes of atrial flutter may be included, provided that AF is the dominant arrhythmia and the primary target of clinical management)
- Implanted electronic device (pacemaker/ICD/ICM)
- Type 1 diabetes or Type 2 diabetes on insulin treatment
- Severe heart failure (LVEF <40%)
- Inability to sign informed consent
- Severe kidney disease (eGFR<30)
- History of catheter ablation for AF
- Scheduled to receive catheter ablation for AF during the study period (next 1 year)
- Incretin-based therapy (GLP-1 receptor agonists or DPP-IV inhibitors) within 30 days prior to randomization (visit 1)
- Scheduled for bariatric surgery during the study period
- Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis
- Chronic or previous acute pancreatitis
- Current participation in any other clinical intervention trial that may result in changes to med-ical management during the study period
- Women of childbearing potential who are not on an acceptable form of contraception
- Pregnant or breastfeeding women
- Personal or family history of medullary thyroid carcinoma (MTC)
- History of MEN2 (Multiple Endocrine Neoplasia type 2)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Intervention
Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA), aiming for >10% weight loss on top of standard care.
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Weight loss period (0-16 weeks): Behavioural support (first step): Dietician-guided lifestyle vhanges through virtual meeting, frequency by patient's choice; energy intake 1500 kcal/day; <30% carbohydrates, >=60 g protein/day, adeqaute fiber, 2-2.5 L/day non-caloric fluids. Escalation strategy (second step): Meal replacement: available free of charge Pharmacotherapy: Semaglutide once weekly subcutaneous injection Target weight loss >10%; aiming for a 1% weight loss per week during the weight loss period. Weight loss maintenance period (17-52 weeks): Maintenance of >10% weigth loss Further lifestyle changes, meal replacement, or dose adjustment of weight loss medication |
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다른: Control
Standard care, including cardiovascular risk factor management, with visit frequency and follow-up similar to the intervention group.
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Guideline-directed cardiovascular risk factor management, including medical treatment and lifestyle counseling.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hierarchical composite outcome capturing AF progression and AF burden, inte-grating clinical events assessed by blinded adjudication and objective measures of AF burden, assessed by 14-day continuous ECG monitoring
기간: From 4 months to 12 months after enrollment
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The hierarchical components of the primary outcome are:
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From 4 months to 12 months after enrollment
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Axel Brandes, M.D., Esbjerg Hospital - University Hospital of Southern Denmark
- 수석 연구원: Eva Prescott, PhD, University Hospital Bispebjerg and Frederiksberg
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- S-20260028
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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