NCT07382024Toborzás még nem indult
Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation
Tirzepatide to Reduce Recurrence and Burden After Catheter Ablation of Atrial Fibrillation: A Prospective Randomized Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 12.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to determine whether tirzepatide can reduce atrial fibrillation (AF) burden after catheter ablation in overweight or obese patients with persistent AF. It will also evaluate the effects of tirzepatide on body weight, metabolic risk factors, and clinical outcomes, as well as its safety and tolerability in this population. The main questions it aims to answer are: 1. Does peri-procedural treatment with tirzepatide reduce AF burden at 3 months after de novo catheter ablation, as measured by 7-day continuous ECG patch monitoring? 2. Does tirzepatide lead to greater weight loss and improvement in metabolic parameters compared with standard care alone? 3. Does tirzepatide reduce AF recurrence and cardiovascular events during 12 months of follow-up? Researchers will conduct a multi-center, open-label, endpoint-blinded, randomized controlled trial in adults aged 18-80 years with persistent AF and body mass index ≥25 kg/m² who are scheduled for de novo catheter ablation. Participants will be randomized 1:1 to receive either tirzepatide plus standard peri-procedural and post-ablation care or standard care alone. Participants in the tirzepatide group will receive subcutaneous tirzepatide 2.5 mg once weekly starting about 4 weeks before ablation and continuing for 3 months afterward, for a total treatment duration of approximately 4 months. All participants will be followed at 1, 2, 3, 6, and 12 months after ablation, with detailed assessment of AF burden, AF recurrence, echocardiographic parameters, metabolic profile, quality of life by the AFEQT questionnaire, and safety events.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2026. jan. 8.
- Kezdés
- 2026. jún. 16.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- National Taiwan University Hospital
- Betegségek
- Pitvarfibrilláció, Elhízás
- NCT-szám
- NCT07382024
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 200
- 2026. jún. 16. és az elsődleges befejezés (2027. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Planned major non-AF-related surgery or interventional procedure within 3 months.
- Contraindications to tirzepatide or GLP-1/GIP receptor agonists (e.g., prior serious hypersensitivity, personal or family history of medullary thyroid carcinoma or MEN2, history of clinically significant pancreatitis, severe gastrointestinal disease that may impair tolerance or absorption).
- Participation in another interventional clinical study within 30 days prior to screening or planned participation during the study period.
Más betegség
- AF secondary to reversible causes (e.g., hyperthyroidism, acute infection, acute pulmonary embolism, recent cardiac surgery).
- Severe structural heart disease that may significantly affect ablation outcomes (e.g., hypertrophic cardiomyopathy, rheumatic valvular disease, dilated cardiomyopathy).
- Other arrhythmias requiring chronic antiarrhythmic drug therapy.
- Active systemic infection at screening.
- Poorly controlled type 1 diabetes, recent diabetic ketoacidosis, end-stage renal disease requiring dialysis, or severe hepatic dysfunction judged clinically significant.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation, including inability to comply with study procedures or follow-up.
Életkor
- Long-standing AF or marked left atrial enlargement (persistent AF duration > 5 years or left atrial anterior-posterior diameter > 50 mm).
Egyéb
- Intracardiac thrombus or any contraindication to catheter ablation as judged by the investigator.
- Pregnancy, breastfeeding, or women of childbearing potential unwilling or unable to use adequate contraception during the study.
Kiket keres a vizsgálat
- Age between 18 and 80 years.
- Diagnosed with persistent atrial fibrillation and scheduled for de novo catheter ablation.
- Body mass index (BMI) ≥27 kg/m² at screening accompanied by at least one weight-related comorbidity (including cardiovascular disease, hypertension, dyslipidemia, or prediabetes).
- Able and willing to provide written informed consent.
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Taiwan University Hospital Cardiovascular Center | Taipei | Tajvan | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.