Cardiac MRI in Rheumatic heart disease

Phase 1

Conditions: Health Condition 1: null- Rheumatic heart disease with established mitral valve disease

Registration Number: CTRI/2018/08/015149

Lead Sponsor: niversity of South Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Asymtpomatic moderate or severe MS (MVA <1.5cm2 or mean PG >5mmHg)

2. Asymptomatic moderate-severe mixed mitral valve disease (mean PG >5).

3. Asymptomatic moderate or severe MR.

Exclusion Criteria

1. Moderate or severe aortic regurgitation as this affects LV dilation that occurs due to mitral regurgitation.

2. 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).

3. Significant ischaemic heart disease (previous MI or known coronary stenosis >70%) as this would affect the stress test and scar results.

4. LV ejection fraction < 60% or LV end-diastolic diameter (LVEDD) >44mm.

5. Participant must not be part of another active trial.

6. Participant must not be pregnant or lactating.

7. 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).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in exercise treadmill test time <br/ ><br>2. Class I indications for surgery/intervention <br/ ><br>3. New atrial fibrillation <br/ ><br>4. Stroke (or transient ischaemic attack (TIA) with CT or MRI evidence of an event) <br/ ><br>5. Surgery or valvuloplasty <br/ ><br>6.Cardiac death (including stroke) <br/ ><br>Timepoint: 1.Change in exercise treadmill test time at six months <br/ ><br>2. Class I indications for surgery/intervention in six months <br/ ><br>3. New atrial fibrillation in six months <br/ ><br>4.Stroke (or transient ischaemic attack in six months (TIA) with CT or MRI evidence of an event) <br/ ><br>5. Surgery or valvuloplasty in six months <br/ ><br>6. Cardiac death (including stroke)i six months

Secondary Outcome Measures

Name	Time	Method
- Change in EQ-5D-5L Health Questionnaire score <br/ ><br>- Change in pro-BNP <br/ ><br>- Hospitalisations <br/ ><br>â?¢Including heart failure related admissions <br/ ><br>- New subclinical atrial fibrillation <br/ ><br>- Atrial fibrillation burden <br/ ><br>Timepoint: Baseline, six months, twelve months and two years