RanolazIne for heart failure with preServed Ejection fraction: [RISE - HFpEF study]
- Conditions
- Health Condition 1: I503- Diastolic (congestive) heart failure
- Registration Number
- CTRI/2022/02/040351
- Lead Sponsor
- Indian Council of Medical Research ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
(All should be satisfied)
1. Patients have diagnosis of symptomatic heart failure with Left Ventricular Ejection Fraction (LVEF) > 45%.
2. Plasma level of NT-proBNP >300 ng/mL
3. NYHA class II to IV heart failure
4. Age � 18 years of either sex.
1. Patients already on treatment with ranolazine or have been administered with ranolazine within past 24 weeks.
2. Patients with Acute Coronary Syndrome, cardiac surgery within period of last 24 weeks.
3. Patients receiving concomitant strong CYP3A4 inhibitor (e.g. diltiazem, verapamil) or inducer (e.g., rifampicin, carbamazepine).
4. Patients who are taking concomitant P glycoprotein inhibitor (e.g cyclosporine).
5. Patients who have participated in another trial in the past 3 months.
6. Patients with history of cardiac arrhythmia or is currently undertaking treatment with antiarrhythmic drugs
7. Anaemia (Hb <8g%)
8. HbA1c >8 g%, (for inclusion of diabetes patients)
9. Pregnancy and lactating mothers
10. not willing to follow contraceptive measures if in reproductive age group
11. Cirrhosis
12. Age > 75 years ( to have upper cut off for age as Ranolazine related ADRs are more in elderly)
13. HR <60 bpm
14. Patients with history, signs and symptoms suggestive of pericardial constriction, cor pulmonale, implanted pacemaker, implanted LVAD, implanted cardioverter - defibrillator, significant pulmonary disease (requiring active treatment with oxygen and steroid), valvular heart disease, acute decompensated heart failure.
16. Patients with congenital or acquired QT interval prolongation, familial history of QT interval prolongation, QTc interval of >450 ms in males and >470 ms in Females.
17. Patients with history of Myocardial infarction, CABG surgeryand PCI in the previous 6 month.
18. Patients with history of uncontrolled hypertension (blood pressure that is inadequately treated rather than blood pressure that is resistant to treatment, as might be observed with secondary causes of hypertension such as renal artery stenosis).
19. Patients with history of valvular heart disease.
20. Patients with significant pulmonary disease, COPD.
21. Patients who have osteoarthritis or any other conditions which would prevent him/her from performing 6 minute walk test
22. Patients with renal creatinine clearance � 30 ml/min (Cockcroft - Gault formula) or with severe hepatic impairment (Child Pugh class B or Class C).
23. Patients who are not willing for follow up at the participating institute for a period of 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change from baseline in 6-minute walk distance (6MWD) at Week 24. <br/ ><br>2. Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24. <br/ ><br>Timepoint: Baseline, 12 weeks, 24 weeks
- Secondary Outcome Measures
Name Time Method