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 condition

Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Ejection Fraction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009207

Enrollment

7000

Registered

2017-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 events Health Condition 2: I258- Other forms of chronic ischemic heart disease

Interventions

Intervention1: Dapagliflozin: Dapagliflozin/Placebo Frequency: Once in a day Route of administration: Oral Total duration of therapy: 24 months Control Intervention1: Placebo: Matching placebo for Dap

Eligibility

Inclusion criteria

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 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

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 4. Current acute decompensated HF or hospitalization due to decompensated HF 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

Design outcomes

Primary

Measure	Time frame
To determine, as a superiority assessment, whether treatment with dapagliflozin 10 mg, when added to standard of care, will reduce the incidence of the composite endpoint of CV death or hospitalization for heart failure or equivalent HF event (hereafter referred to as Heart Failure Event)Timepoint: Time to the first occurrence of any of the components of this composite: 1. CV death 2. Hospitalisation for heart failure 3. An urgent heart failure visit	—

Measure

Time frame

To determine, as a superiority assessment, whether treatment with dapagliflozin 10 mg, when added to standard of care, will reduce the incidence of the composite endpoint of CV death or hospitalization for heart failure or equivalent HF event (hereafter referred to as Heart Failure Event)Timepoint: Time to the first occurrence of any of the components of this composite: 1. CV death 2. Hospitalisation for heart failure 3. An urgent heart failure visit

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Secondary

Measure	Time frame
To compare the effect of dapagliflozin versus placebo on CV death or hospitalization for HFTimepoint: Time to the first occurrence of any of the components of this composite: 1. CV death 2. Hospitalization for HF;To compare the effect of dapagliflozin versus placebo on total number of recurrent HF hospitalizations and CV death.Timepoint: Total number of recurrent HF hospitalizations and CV death.;To compare the effect of treatment with dapagliflozin versus placebo on the KCCQ clinical summary score for HF symptoms and physical limitations.Timepoint: Change from baseline measured at 8 months in the overall summary score of the KCCQ, a specific HF patient reported outcome questionnaire.;To determine if dapagliflozin compared with placebo reduces the incidence of a worsening renal function composite outcomeTimepoint: Time to the first occurrence of any of the components of this composite: 1. â?¥50% sustained decline in eGFR 2. Reaching End Stage Renal Disease - Sustained eGFR less than 15 ml/min/1.73m2 or - Chronic dialysis treatment or - Receiving a renal transplant 3. Renal death	—

Measure

Time frame

To compare the effect of dapagliflozin versus placebo on CV death or hospitalization for HFTimepoint: Time to the first occurrence of any of the components of this composite: 1. CV death 2. Hospitalization for HF;To compare the effect of dapagliflozin versus placebo on total number of recurrent HF hospitalizations and CV death.Timepoint: Total number of recurrent HF hospitalizations and CV death.;To compare the effect of treatment with dapagliflozin versus placebo on the KCCQ clinical summary score for HF symptoms and physical limitations.Timepoint: Change from baseline measured at 8 months in the overall summary score of the KCCQ, a specific HF patient reported outcome questionnaire.;To determine if dapagliflozin compared with placebo reduces the incidence of a worsening renal function composite outcomeTimepoint: Time to the first occurrence of any of the components of this composite: 1. â?¥50% sustained decline in eGFR 2. Reaching End Stage Renal Disease - Sustained eGFR less than 15 ml/min/1.73m2 or - Chronic dialysis treatment or - Receiving a renal transplant 3. Renal death

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Countries

Argentina, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Germany, Hungary, India, Japan, Netherlands, Poland, Romania, Russian Federation, Slovakia, Sweden, Taiwan, United Kingdom, United States of America, Viet Nam

Contacts

Public ContactMr Tapankumar M Shah

AstraZeneca Pharma India Limited

tapankumar.shah@astrazeneca.com91-9535104975

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026