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Clinical Trials/CTRI/2018/08/015149
CTRI/2018/08/015149
Not yet recruiting
Phase 1

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

niversity of South Australia0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: null- Rheumatic heart disease with established mitral valve disease

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: null- Rheumatic heart disease with established mitral valve disease
Sponsor
niversity of South Australia
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
niversity of South Australia

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Not specified

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