Atrial Fibrillation Among Patients With Hematologic Malignancies on Tyrosine Kinase Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Incidence of Atrial Fibrillation
研究概览
简要总结
This study looks at how often atrial fibrillation (AF), an irregular heart rhythm, occurs in people with certain blood cancers who are starting a type of cancer medicine called a Bruton's tyrosine kinase inhibitor (BTKI). Researchers will follow 400 people starting BTKI therapy and compare them to 100 people with similar blood cancers who are not taking a BTKI. Participants will wear a smartwatch and, later, a heart monitor patch to check for AF and other irregular heart rhythms over 12 months. The study will also look at whether AF affects cancer treatment, such as needing to pause, lower the dose, or stop the BTKI, and whether it leads to other health problems such as bleeding, stroke, or heart-related hospital visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Diagnosis of chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL)
- •New initiation of Bruton's tyrosine kinase inhibitor (BTKI) therapy or non-BTKI therapy (eg, venetoclax based) for management of hematologic malignancy
排除标准
- •Prior exposure to BTKI therapy
- •History of persistent atrial fibrillation
结局指标
主要结局
Incidence of Atrial Fibrillation
时间窗: Up to 12 months
Incidence of new atrial fibrillation (AF) detected by smartwatch photoplethysmography with confirmatory ECG, and/or by 14-day ECG patch monitor, compared between participants on BTKI therapy and non-BTKI control participants.
次要结局
- Hospital Admission for Atrial Fibrillation or Other Arrhythmias(Up to 12 months)
- AF Burden on BTKI Therapy(Up to 12 months)
- Incidence of Other Arrhythmias(Up to 12 months)
- Clinical Atrial Fibrillation Diagnosis Not Detected by Smartwatch or ECG Patch Monitor(Up to 12 months)
- BTKI Therapy Interruption, Dose Reduction, or Cessation Due to Arrhythmia(Up to 12 months)
- New Clinical Diagnosis of Hypertension(Up to 12 months)
- Prescription of Antiplatelet, Anticoagulant, or Rate/Rhythm Control Medication for Atrial Fibrillation(Up to 12 months)
- Incidence of Major Bleeding Events(Up to 12 months)
- Incidence of Major Adverse Cardiovascular Events (MACE)(Up to 12 months)
- Referral to Cardiology or Electrophysiology(Up to 12 months)
- Overall Survival(At 12 months)
研究者
Tina Baykaner
Assistant Professor of Medicine (Cardiovascular Medicine)
Stanford University