Health Condition 1: I420- Dilated cardiomyopathy
Conditions
Interventions
Intervention1: Ivabradine: Dose : 2.5 mg,
Frequency : Twice a day [B.D],
Duration : 8 weeks.
Control Intervention1: STANDARD TREATMENT: ANGIOTENSIN CONVERTING ENZYME INHIBITORS
ANGIOTENSIN RECEPTOR BL
Sponsors
SRM College of Pharmacy
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with dilated cardiomyopathy and normal sinus rhythm with heart rate >= 75 beats per minute and dilated cardiomyopathy of NYHA class II and III with LVEF 2.Patient willing to perform six-minute walk test and donâ??t have any orthopedic limitations
Exclusion criteria
Exclusion criteria: 1.Patient with Acute Heart Failure, Acute Myocardial Infarction, Stroke, Transient Ischemic attack and Patients who are Pacemaker Dependent 2. Patient with other co-morbid disease conditions such as End Stage Renal Disease, Hepatic Impairment and Pulmonary Diseases 3. Patient taking Concomitant Strong Potent CYP3A4 Inhibitors 4. Pregnancy and Lactating women 5. Patients who are in Treatment with non dihydropyridine CCB, C-I Anti Arrhythmic agents and QTc Interval Prolonging Medications. 6. Any Known Contraindications or Hypersensitivity to Ivabradine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in Exercise Capacity as measured by 6-minute walk test compared to standard treatment. 2.Improvement in NT pro-BNP biomarker levels compared to standard treatment.Timepoint: 0 and end of 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in dyspnea and fatigue assessed by using Borgs scale. 2.Improvement in patient health related quality of life assessed by using Minnesota Living with Heart Failure Questionnaire. 3.Improvement in effect of patient counselling on medication adherence assessed by using Medication Adherence Rating Scale.Timepoint: 0 and end of 8 weeks | — |
Countries
India
Contacts
Public ContactDr T M VIJAYAKUMAR
Department of Cardiology, SRM Medical College Hospital and Research Centre
Outcome results
None listed