Health Condition 1: I278- Other specified pulmonary heart diseases
Conditions
Interventions
Intervention1: Metoprolol succinate-controlled release tablets: Treatment group
will Receive Metoprolol succinate-controlled release oral tablet
Dosage is 25 mg/day for first 2 weeks followed by 50
Sponsors
Dr Satyavir Yadav
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in 6MWT distance between the treatment group receiving Metoprolol succinate and placebo group at 16 weeks of treatmentTimepoint: at 16 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1, Change in resting saturation 2, Clinical composite outcome (all cause death, heart failure hospitalisation, worsening of heart failure, change in WHO functional class, and new onset syncope) 3, Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) 4, Change in BNP levels Timepoint: At 16 weeks of treatment | — |
Countries
India
Contacts
Public ContactDr Aswin Pius
All Institute of medical sciences , New Delhi
Outcome results
None listed