A study to assess the efficacy and safety of Dapagliflozin and Sacubitril/Valsartan Tablets in heart disease patients.
- Conditions
- Health Condition 1: I509- Heart failure, unspecified
- Registration Number
- CTRI/2024/03/064908
- Lead Sponsor
- Exemed Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean improvement of ejection fraction (EF) from baseline to end of the study visit (Week 24).Timepoint: Visit 1 - Screening or Baseline visit (Day -7), <br/ ><br>Visit 5 - Follow up visit / Week 12 (Day 84±3) and <br/ ><br>Visit 7 - End of the study visit / Week 24 (Day 168±3).
- Secondary Outcome Measures
Name Time Method