MRI to Aid Surgical Timing Decision in Rheumatic Heart Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. Change in exercise treadmill test time
研究概览
简要总结
This is a prospective, multi-centre observational study looking at baseline, one year, and two year changes in cardiac function compared to clinical outcomes in participants with rheumatic heart disease and examining whether CMR can predict outcomes better than echocardiography or exercise stress testing alone. This will aim to enrol 45 asymptomatic patients with RHD from CMC Vellore (15 severe MS, 15 moderate MMVD, 15 severe MR).
The date of birth, body weight, height, gender, race and all medications will be collected. The medical history of the participant will also be recorded. Heart failure related hospitalisations, new symptoms, new atrial fibrillation and strokes will be recorded. Participants will complete the EQ-5D-5L Health Questionnaire at regular intervals. Blood will be drawn and processed to determine the creatinine, haemoglobin, haematocrit, CRP and BNP. A regular and comprehensive TTE with 3D is standard of care for every participant with mitral valve disease. LV strain, left atrial LA ejection fraction and LA systolic function requires no additional views to the standard echocardiogram for comprehensive mitral valve assessment. Images for these novel indices will be assessed offline using customized software. An exercise stress test for evaluation of symptoms and changes in pulmonary pressures will be performed yearly.
The minimum target number of participants for each group in this study is 20. This is based upon power calculations showing that 16 patients would be needed to show a 10% reduction in exercise treadmill time with an α of 0.05 and 80% power.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Asymtpomatic moderate or severe MS (MVA<1.5cm2 or mean PG >5mmHg)
- •Asymptomatic moderate-severe mixed mitral valve disease (mean PG>5).
- •Asymptomatic moderate or severe MR.
排除标准
- •Moderate or severe aortic regurgitation as this affects LV dilation that occurs due to mitral regurgitation.
- •Any other severe valvular lesion as this would confound the data (tricuspid, pulmonary and aortic lesions that are moderate in severity are acceptable excluding moderate aortic regurgitation).
- •Significant ischaemic heart disease (previous MI or known coronary stenosis >70%) as this would affect the stress test and scar results.
- •LV ejection fraction < 60% or LV end-diastolic diameter (LVEDD) >44mm.
- •Participant must not be part of another active trial.
- •Participant must not be pregnant or lactating.
- •Other severe comorbid condition, concurrent medication, or other issue that renders the participant unsuitable for participation in the study (e.g. exercise limiting lung disease).
结局指标
主要结局
1. Change in exercise treadmill test time
时间窗: 1.Change in exercise treadmill test time at six months | 2. Class I indications for surgery/intervention in six months | 3. New atrial fibrillation in six months | 4.Stroke (or transient ischaemic attack in six months (TIA) with CT or MRI evidence of an event) | 5. Surgery or valvuloplasty in six months | 6. Cardiac death (including stroke)i six months
2. Class I indications for surgery/intervention
时间窗: 1.Change in exercise treadmill test time at six months | 2. Class I indications for surgery/intervention in six months | 3. New atrial fibrillation in six months | 4.Stroke (or transient ischaemic attack in six months (TIA) with CT or MRI evidence of an event) | 5. Surgery or valvuloplasty in six months | 6. Cardiac death (including stroke)i six months
3. New atrial fibrillation
时间窗: 1.Change in exercise treadmill test time at six months | 2. Class I indications for surgery/intervention in six months | 3. New atrial fibrillation in six months | 4.Stroke (or transient ischaemic attack in six months (TIA) with CT or MRI evidence of an event) | 5. Surgery or valvuloplasty in six months | 6. Cardiac death (including stroke)i six months
4. Stroke (or transient ischaemic attack (TIA) with CT or MRI evidence of an event)
时间窗: 1.Change in exercise treadmill test time at six months | 2. Class I indications for surgery/intervention in six months | 3. New atrial fibrillation in six months | 4.Stroke (or transient ischaemic attack in six months (TIA) with CT or MRI evidence of an event) | 5. Surgery or valvuloplasty in six months | 6. Cardiac death (including stroke)i six months
5. Surgery or valvuloplasty
时间窗: 1.Change in exercise treadmill test time at six months | 2. Class I indications for surgery/intervention in six months | 3. New atrial fibrillation in six months | 4.Stroke (or transient ischaemic attack in six months (TIA) with CT or MRI evidence of an event) | 5. Surgery or valvuloplasty in six months | 6. Cardiac death (including stroke)i six months
6.Cardiac death (including stroke)
时间窗: 1.Change in exercise treadmill test time at six months | 2. Class I indications for surgery/intervention in six months | 3. New atrial fibrillation in six months | 4.Stroke (or transient ischaemic attack in six months (TIA) with CT or MRI evidence of an event) | 5. Surgery or valvuloplasty in six months | 6. Cardiac death (including stroke)i six months
次要结局
- - Change in EQ-5D-5L Health Questionnaire score(- Change in pro-BNP)