Health Condition 1: I099- Rheumatic heart disease, unspecified
Conditions
Interventions
Intervention1: Digoxin: In order to preserve
the pragmatic nature of the trial, no specific dosing regimen will be mandated for trial
participants. Physicians will be allowed to follow other accepted
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. RHD documented by echocardiography 3. Already on treatment with digoxin as advised by their treating doctors 4. Not already on digoxin, but haveeither of the following conditions: i. Heart failure - diagnosed in the presence of current or past clinical symptoms (limitation of activity, fatigue, and dyspnea, orthopnea or paroxysmal nocturnal dyspnea), signs (edema, elevated jugular venous pressure, or rales), or radiologic evidence of pulmonary congestion ii. Atrial fibrillation or flutter -documented on a 12-lead ECG
Exclusion criteria
Exclusion criteria: 1. Significant renal insufficiency (serum creatinine >2 mg/dL) 2. Uncorrected hypokalemia ( hyperkalemia ( >5.5 mmol/L) 3. Presence of sinus bradycardia (HR II or III degree AV block, sick sinus syndrome or pre-excitation 4. Physician does not wish to start digoxin 5. Coexisting coronary artery disease or other cardiac conditions (hypertrophic, dilated or restrictive cardiomyopathies) 6. Patients with mechanical heart valves (however, patients who undergo mechanical valve replacement surgery during the course of the study will be continued on study drug) 7. Pregnant women 8. Presence of severe comorbid conditions which may limit life expectancy to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of all-cause death and new or worsening heart failureTimepoint: every three months till minimum 18 months and maximum 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Death due to HFTimepoint: every three months till minimum 18 months and maximum 36 months;All-cause death Timepoint: every three months till minimum 18 months and maximum 36 months;Composite of HF-related death or hospitalisation for HFTimepoint: every three months till minimum 18 months and maximum 36 months;Composite of HF-related death, new-onset or worsening heart failureTimepoint: every three months till minimum 18 months and maximum 36 months;Hospitalisation for HFTimepoint: every three months till minimum 18 months and maximum 36 months;New-onset or worsening heart failureTimepoint: every three months till minimum 18 months and maximum 36 months;Quality of life (EQ-5D-5L)Timepoint: At baseline, 12 months, 18 months and 24 months;Sudden deathTimepoint: every three months till minimum 18 months and maximum 36 months | — |
Countries
India
Contacts
Public ContactGanesan Karthikeyan
All India Institute of Medical Sciences
Outcome results
None listed