A clinical trial to determine if the test drug (Dapagliflozin) is better that placebo (Dummy drug) when used along with the standard therapy in patients with chronic heart failure in reducing incidence of worsening of this conditio

Phase 3

• Conditions: Health Condition 1: null- Men and women â?¥18 years of age with an established diagnosis of HFrEF for â?¥ 2 months and at a high risk of CV death or HF eventsHealth Condition 2: I258- Other forms of chronic ischemic heart disease

• Registration Number: CTRI/2017/08/009207
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Provision of signed informed consent prior to any study specific procedures

2. Male or female, aged >=18 years at the time of consent

3. Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months and is optimally treated with pharmacological and/or device therapy, as indicated

4. LVEF<=40% (echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) within the last 12 months prior to enrolment (Visit 1)

5. NT-proBNP >600 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP >=400 pg/ml) at enrolment (visit 1)

Exclusion Criteria

1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor

2. Type 1 diabetes mellitus (T1D)

3. Symptomatic hypotension or systolic BP <95 mmHg on 2 consecutive measurements

4. Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment

5. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment

6. Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization

7. Implantation of a cardiac CRT within 12 weeks prior to enrolment or intent to implant a CRT device

8. Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified