Cardiac MRI in Rheumatic heart disease

MRI to Aid Surgical Timing Decision in Rheumatic Heart Disease - MASTD-RHD

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/08/015149

Enrollment

Registered

2018-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Asymtpomatic moderate or severe MS (MVA 5mmHg) 2. Asymptomatic moderate-severe mixed mitral valve disease (mean PG >5). 3. Asymptomatic moderate or severe MR.

Exclusion criteria

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 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).

Design outcomes

Primary

Measure	Time frame
1. Change in exercise treadmill test time 2. Class I indications for surgery/intervention 3. New atrial fibrillation 4. Stroke (or transient ischaemic attack (TIA) with CT or MRI evidence of an event) 5. Surgery or valvuloplasty 6.Cardiac death (including stroke) Timepoint: 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	—

Measure

Time frame

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

—

Secondary

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

Countries

Australia, India

Contacts

Public ContactVarsha Kiron

Christian Medical College and Hospital, Vellore

kironvarsha@gmail.com04162282698

Outcome results