NL-OMON52120招募中不适用
Bariatric surgery Evaluation and Assessment of Treatment efficacy in heart failure and preserved ejection fraction - Intervention Trial - BEAT-IT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signs and symptoms of HF according to the European Society of Cardiology
- •guidelines.
- •2. Left ventricular ejection fraction >=40%.
- •3. HFA-PEFF score >=5 or HFA-PEFF score 2-4 in combination with positive stress
- •4. Between 45 and 70 years of age.
- •5. BMI 32-40 kg/m2.
- •6. Paroxysmal or persistent AF with a rhythm control strategy.
- •7. Willing to undergo both treatment strategies.
- •8. Written informed consent
排除标准
- •1. BMI >=40 kg/m2.
- •2. BMI <32 kg/m2.
- •3. Patients unwilling or unable to sign informed consent.
- •4. More than moderate mitral valve regurgitation/aortic valve regurgitation.
- •5. More than mild mitral valve stenosis/aortic valve stenosis.
- •6. Inadequate echocardiographic window for the assessment of LV mass index
- •and/or the echocardiographic criteria needed for the HFA-PEFF score
- •7. History of myocardial infarction, myocarditis, any invasive cardiac
- •intervention (e.g. surgery, percutaneous coronary intervention, ablation) or
- •stroke, <3 months before inclusion.
- •8. Scheduled for AF ablation.
- •9. Complex congenital heart disease.
- •10. Negative treatment advise from a specialized psychiatrist due to
- •non-stabilized psychotic disorders, severe depression and/or personality
- •11. Patients unable to care for themselves or who are unable adapt to inherent
- •life-style changes following bariatric surgery.
- •12. Any medical condition that limits life span <2 years.
- •13. Diseases requiring long term use of anti-inflammatory treatments.
- •14. The use of medication associated with substantial effects (>5 kg) on body
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