Effects of Metoprolol therapy in patients with Eisenmenger Syndrome
Not Applicable
- Conditions
- Health Condition 1: I278- Other specified pulmonary heart diseases
- Registration Number
- CTRI/2022/09/045620
- Lead Sponsor
- Dr Satyavir Yadav
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Patients more than 12 years of age
2 Patients with unequivocal diagnosis of Eisenmenger
Syndrome
2 Systemic saturation less than or equal to 92%
3 WHO functional class II, III
Exclusion Criteria
1 Uncontrolled Congestive cardiac failure
2 Patients with Severe LV dysfunction LVEF less than or equal to 40%
3 Baseline 6MWT less than or equal to 165 meters
4 Patients in WHO functional class IV
5 Pregnancy
6 Complex congenital CHD with increased QP
7 Any contraindications to beta blockers
8 Patients already on beta blockers
9 Any other compelling indications for beta blocker therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference in 6MWT distance between the treatment group receiving Metoprolol <br/ ><br>succinate and placebo group at 16 weeks of treatmentTimepoint: at 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method 1, Change in resting saturation <br/ ><br> <br/ ><br>2, Clinical composite outcome (all cause death, heart failure hospitalisation, worsening of heart <br/ ><br>failure, change in WHO functional class, and new onset syncope) <br/ ><br> <br/ ><br>3, Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) <br/ ><br> <br/ ><br>4, Change in BNP levels <br/ ><br>Timepoint: At 16 weeks of treatment