Study of Ranolazine in Heart Failure
- Conditions
- Health Condition 1: I503- Diastolic (congestive) heart failure
- Registration Number
- CTRI/2019/02/017766
- Lead Sponsor
- Postgraduate Institute of Medical Education and Research PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient of Heart failure with preserved Ejection Fraction (HFpEF). The diagnosis of HFpEF requires the following conditions to be satisfied: (i) signs or symptoms of heart failure; (ii) normal or mildly abnormal systolic LV function; (iii) evidence of diastolic LV dysfunction. Normal or mildly abnormal systolic LV function implies
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both an Left Ventricular Ejection Fraction (LVEF) > 50% and an LV end-diastolic volume index (LVEDVI) < 97 mL/m2. The diastolic LV dysfunction is evidenced by Tissue doppler E/Eâ?? greater than 15. If E/Eâ?? is between 8 to 15, then the diagnosis should be confirmed by plasma level of NT-proBNP > 220 pg/ml (1).
2. Patient of either sex. Female participant should not be pregnant (negative urinary pregnancy test) during the time of screening and should be ready to follow at least 2 contraceptive measures.
3. Age >= 18 years
4. Diagnosed as NYHA class II or III heart failure and having symptoms of heart failure at the time of screening and is on treatment with minimum of one drug for HF.
5. Should give informed consent for participating in study.
1. Patient already on treatment with ranolazine or have been administered with ranolazine over a period of past 6 months.
2. Patient with Acute Coronary Syndrome, cardiac surgery within period of 6 months.
3. On concomitant strong CYP3A4 inhibitor (e.g. Diltiazem, verapamil) or inducer (e.g., Rifampicin, carbamazepine and St John Wort).
4. Patient who are taking concomitant P glycoprotein inhibitor (e.g Cyclosporine).
5. Patient who have participated in another trial in the past 3 months.
6. Patient with history of cardiac arrhythmia (severe in nature) or is currently undertaking treatment with 2 or more antiarrhythmic drugs
7. Patient with pericardial constriction, cor pulmonale, congenital QT interval prolongation, acquired QT interval prolongation, familial history of QT interval prolongation, implanted pacemaker, implanted LVAD, implanted cardioverter -
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defibrillator, significant pulmonary disease (requiring active treatment with oxygen and steroid), acute decompensated heart failure.
8. Patient with history of Myocardial infarction, CABG surgery in the previous 3 months, and PCI in the previous 1 month.
9. Patient with significant pulmonary disease, COPD (severe in nature).
10. Patient who had been prescribed with ranolazine previously.
11. Patient who have osteoarthritis or any other abnormality/ pathology of limbs which would prevent him from performing in exercise test.
12. Patient with renal creatinine clearance <= 30 ml/min (Cockcroft - gault formula) or with severe hepatic impairment (Child Pugh class B or Class C).
13. Patient who are not willing for manual follow up at our institute (PGIMER, Chandigarh) for a period of 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the biomarker concentration over a period of 6 months as compared to that of baseline in ranolazine vs placebo group. The biomarker which would be measured include NT-proBNP (biomarker for prognosis), Von-willebrand Factor (biomarker for long term mortality) and Syndecan - I (biomarker of fibrosis)Timepoint: Baseline and 6th month
- Secondary Outcome Measures
Name Time Method All-cause mortalityTimepoint: 6th month;Cardiovascular mortalityTimepoint: 6th month;Composite score of CV death, total HF hospitalizations, total non-fatal strokes and total non-fatal myocardial infarctionTimepoint: 6th month;Echocardiographic parameters: <br/ ><br>a. LVEDV in ml <br/ ><br>b. LVEDVI in ml/kg <br/ ><br>c. LVESV in ml <br/ ><br>d. LVESVI in ml/kg <br/ ><br>e. LVSV in ml <br/ ><br>f. LVEF in % <br/ ><br>g. Mitral E in cm/s <br/ ><br>h. Mitral A in cm/s <br/ ><br>i. Mitral E/A <br/ ><br>j. Mitral Eâ?? in cm/s <br/ ><br>k. E/Eâ??Timepoint: Baseline and 6th month;Frequency of occurrence of adverse events between ranolazine and placebo groupTimepoint: 6th month;NYHA(New York Heart Association ) scoreTimepoint: Baseline and 6th month;Proportion of patients hospitalizedTimepoint: 6th month;Quality of life score as assessed by employing the Kansas City Cardiomyopathy QuestionnaireTimepoint: Baseline and 6th month;Time to event analysis with all-cause mortality as the endpointTimepoint: 6th month