CTRI/2025/02/080247已完成3 期
A Phase III, Prospective, Randomized, Double Blind, Active Controlled, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Eplerenone plus Torsemide Tablets Versus Fixed Dose Combination of Spironolactone plus Torsemide Tablets in Patients with Congestive Heart Failure.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 18
- 主要终点
- At least one class improvement in NYHA functional class from baseline to end of the study visit (Week 24).
研究概览
简要总结
This is a Phase III, Prospective, Randomized, Double Blind, Active Controlled, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Eplerenone plus Torsemide Tablets Versus Fixed Dose Combination of Spironolactone plus Torsemide Tablets in Patients with Congestive Heart Failure.
Patients who are willing and able to participate in the study will sign and date the Informed Consent Form on the day of screening visit (Visit 1). During this screening period, patients who are willing to give consent will be evaluated for all the eligibility criteria. Eligible patients (male or female) aged between 18 years and above meeting all the inclusion criteria and none of the exclusion criteria prior to screening will be considered for the study.
After confirming the inclusion/exclusion criteria the subject will be randomized and provided with study medication at randomization visit. Subjects will be provided with patient diary at randomization visit, which need to be brought along with in each subsequent visit till the last visit. Follow up visits will be done on week 2/day 14(±3), week 6/day 42(±3), week 12/day 84(±3), week 18/day 126(±3) and week 24/day 168(±3) (final visit) of treatment to assess efficacy, safety and tolerability.
Patients will be assigned to either of the three arms i.e., Arm A or Arm B or Arm C consisting of FDC of Eplerenone 25 mg + Torsemide 10 mg Tablets or FDC of Eplerenone 25 mg
- Torsemide 20 mg Tablets or FDC of Spironolactone 25 mg + Torsemide 20 mg Tablets. Patients will be advised to take one tablet once daily orally, swallowed with water around same time every day for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged more than 18 years with documented diagnosis of congestive heart failure at the time of screening visit.
- •Patients with New York Heart Association (NYHA) functional class II or III symptoms at the time of screening visit.
- •Patients with ejection fraction (EF) less than 40% at the time of screening visit.
- •Patients with a plasma level of NT-pro BNP (N-terminal pro-B type natriuretic peptide) should be more than 120 pg/mL at the time of screening visit.
- •Patients should receive a background standard of care for congestive heart failure and be treated according to locally recognized guidelines.
- •Guideline recommended pharmacological medications should be used at recommended doses unless contraindicated or not tolerated (“ACE inhibitor†OR “ARB†and a “beta-blockerâ€).
- •Therapy should have been individually optimized and stable for more than or equal to 4 weeks.
- •Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study.
- •WOCBP must have a negative urine pregnancy test at screening / baseline visit.
- •Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Patients are willing to comply with the protocol requirements throughout the study.
排除标准
- •Patients with known hypersensitivity to study medication or related class of drugs.
- •Patients with history or present symptoms of bradycardia (pulse rate less than 60 bpm) and or hypotension (systolic blood pressure less than 95 mmHg and diastolic blood pressure less than 70 mmHg) with or without treatment with beta-blockers at 2 out of 3 measurements either at screening or randomization.
- •Patients with symptoms recent worsening heart failure or other cardiovascular events or procedures (or planned procedures).
- •Patients with hypoxia, a room air saturation of less than 95%.
- •Patients with ongoing myocardial ischemia requiring revascularization.
- •Patients with present or history of hypokalemia (serum potassium level of less than 3.5 mEq per litre) or hyperkalemia (serum potassium level of more than 5.5 mEq per litre) at screening visit.
- •Patients with hyponatremia as per blood biochemistry results at screening visit.
- •Patients with a history of type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
- •Patients with type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value more than or equal to 8%.
- •Patients with history of angioedema and multi-organ dysfunction.
- •Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
- •Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
- •Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and or Total bilirubin more than 2X the UNL) at screening.
- •Patients with clinically significant renal disorders: Estimated glomerular filtration rate: less than 30 mL per min per 1.73 m
- •Serum creatinine and blood urea nitrogen (BUN) values more than or equal to 1.5 times the upper limit of normal.
- •Patients with MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to randomization.
- •Patients with Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair or replacement within 12 weeks prior to randomization or planned to undergo any of these operations after randomization.
- •Patients with implantation of a cardiac CRT within 12 weeks prior to enrolment or intent to implant a CRT device.
- •Patients with previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization.
- •Patients with HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
- •Patients with symptomatic bradycardia or second or third degree heart block without a pacemaker.
- •Patients with any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator’s clinical judgement.
- •Patients with an active or history of malignancy requiring treatment.
- •Patients with EF less than 25% as per Simpson’s method on 2D Echo.
- •Patients with known case of infection with hepatitis B, hepatitis C or HIV.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
- •Patients currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period.
- •Patients with suspected inability or unwillingness to comply with the study procedures.
- •Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
结局指标
主要结局
At least one class improvement in NYHA functional class from baseline to end of the study visit (Week 24).
时间窗: At Visit 1 - Screening or Baseline visit, | Visit 3 - Follow up visit or Week 2 (Day 14±3), | Visit 4 - Follow up visit or Week 6 (Day 42±3), | Visit 5 - Follow up visit or Week 12 (Day 84±3), | Visit 6 - Follow up visit or Week 18 (Day 126±3) and | Visit 7 - End of the study visit or Week 24 (Day 168±3).
次要结局
- Adverse events and Serious adverse events reported during the study.
- Changes in clinical laboratory parameters from baseline to end of the study visit (Week 24).
- Mean improvement in NYHA functional class from baseline to end of the study visit (Week 24).(At Visit 1 - Screening or Baseline visit,)
- Mean improvement of ejection fraction (EF) from baseline to end of the study visit (Week 24).(At Visit 1 - Screening or Baseline visit,)
- Mean change in the potassium levels from baseline to end of the study visit (Week 24).(At Visit 1 - Screening or Baseline visit,)
- Mean change in plasma NT-pro BNP levels from baseline to end of the study visit (Week 24).(At Visit 1 - Screening or Baseline visit,)
- Mean changes in vital parameters (blood pressure and heart rate) from baseline to end of the study visit (Week 24).(At Visit 1 - Screening or Baseline visit,)
- Worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) from baseline to end of the study visit (Week 24).
研究者
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.
研究点 (18)
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