CTRI/2019/02/017766尚未招募未知
Efficacy and safety of ranolazine in Heart Failure with preserved EjectionFraction (HFpEF) - a randomised, double-blind, placebo-controlled trial - RIPHFPEF
Postgraduate Institute of Medical Education and Research PGIMER Chandigarh0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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.
排除标准
- •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 -
- •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.
研究者
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