Effect of Ivabradine in Dilated cardiomyopathy patients
- Conditions
- Health Condition 1: I420- Dilated cardiomyopathy
- Registration Number
- CTRI/2020/03/023767
- Lead Sponsor
- SRM College of Pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 <= 40 % at the time of screening
2.Patient willing to perform six-minute walk test and donâ??t have any orthopedic limitations
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Improvement in Exercise Capacity as measured by 6-minute walk test compared to standard treatment. <br/ ><br>2.Improvement in NT pro-BNP biomarker levels compared to standard treatment.Timepoint: 0 and end of 8 weeks
- Secondary Outcome Measures
Name Time Method 1.Improvement in dyspnea and fatigue assessed by using Borgs scale. <br/ ><br>2.Improvement in patient health related quality of life assessed by using Minnesota Living with Heart Failure Questionnaire. <br/ ><br>3.Improvement in effect of patient counselling on medication adherence assessed by using Medication Adherence Rating Scale.Timepoint: 0 and end of 8 weeks