CTRI/2024/03/064908尚未招募3 期
A Phase III, Randomized, Open Label, Active-Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Dapagliflozin and Sacubitril/Valsartan Tablets Versus Concomitant Administration of Dapagliflozin and Sacubitril/Valsartan Tablets in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF). - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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.Male or female patients aged Greater than 18 years diagnosed with heart failure with reduced ejection fraction (HFrEF) with EF less than or equal to 40%.
- •2.Patients with established documented diagnosis of symptomatic HFrEF (New York Heart Association (NYHA) functional class II-III).
- •3.Patients should be on maximum dose of Sacubitril/Valsartan Tablets 97/103 mg twice daily.
- •4.Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines with both drugs and devices, as appropriate. Guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated.
- •5.Patients with elevated N-terminal pro-B type natriuretic peptide (NT-proBNP) levels at the time of screening visit.
- •6.Patients with estimated glomerular filtration rate (eGFR) =30 ml/min/1.73 m2 at screening visit.
- •7.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.
- •8.Patient with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening.
- •9.Patients willing to comply with all the protocol related requirements.
排除标准
- •1.Patients with a history of type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
- •2.Patients with a history of metabolic acidosis or diabetic ketoacidosis.
- •3.Patients with symptoms of hypotension or systolic blood pressure Less than 95 mmHg, recent worsening heart failure or other cardiovascular events or procedures (or planned procedures).
- •4.Patients with hypoxia, a room air saturation of less than 95%.
- •5.Patients with ongoing myocardial ischemia requiring revascularization.
- •6.Patients with present or history of hyperkalemia (serum potassium level of more than 5.5 mEq per litre).
- •7.Patients with type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value Greater than or Equal to 8%.
- •8.Patients receiving treatment for type 2 diabetes mellitus with SGLT2 inhibitors within 8 weeks prior to screening visit.
- •9.Patients with history of angioedema and multi-organ dysfunction.
- •10.Patients with a history of genital mycotic infections.
- •11.Patients with intolerance, contraindication or potential allergy/hypersensitivity to SGLT-2 inhibitors.
- •12.Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
- •13.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).
- •14.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.
- •15.Patients with current acute decompensated HF or hospitalization due to decompensated HF less than 4 weeks prior to enrolment.
- •16.Patients with MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to randomization.
- •17.Patients with Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to randomization or planned to undergo any of these operations after randomization.
- •18.Patients with implantation of a cardiac CRT within 12 weeks prior to enrolment or intent to implant a CRT device.
- •19.Patients with previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization.
- •20.Patients with HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
- •21.Patients with symptomatic bradycardia or second or third degree heart block without a pacemaker.
- •22.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.
- •23.Patients with an active or history of malignancy requiring treatment.
- •24.Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •25.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.
- •26.Patients curren
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