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

Phase 3

Active, not recruiting

• Conditions: Other forms of chronic ischemic heart disease,

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

Brief Summary

This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study to investigate whether dapagliflozin versus placebo, given once daily, compared with placebo, reduces the incidence of the composite endpoint of CV death or HF event (hospitalization for HF or equivalent event (i.e. an urgent HF visit)) when added to background standard of care treatment. The primary outcome will be Time to the first occurrence of any of the components of CV death, Hospitalisation for heart failure, An urgent heart failure visit**.** The study will be conducted in about 30 centres in India and globally around 20-25 countries. The sample size from India could be around 700 patients and 7000 patients from rest of the world. The duration of the study will be around 4 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-14
• Last Update Posted: 2021-01-09

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

• 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

• 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

Primary Outcome Measures

Name	Time	Method
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)	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

Secondary Outcome Measures

Name	Time	Method
To compare the effect of treatment with dapagliflozin versus placebo on the KCCQ	clinical summary score for HF symptoms and physical limitations.
To compare the effect of dapagliflozin versus placebo on CV death or hospitalization for HF	Time to the first occurrence of any of the components of this composite:
To determine if dapagliflozin compared with	placebo reduces the incidence of a worsening
To compare the effect of dapagliflozin versus placebo on total number of recurrent HF hospitalizations and CV death.	Total number of recurrent HF hospitalizations and CV death.

Trial Locations

Locations (18)

Artemis Hospital; 🇮🇳 Gurgaon, HARYANA, India

B.J.G.M.C. & Sasoon General Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Bhanubhai and Madhunben Patel Cardiac Centre; 🇮🇳 Anand, GUJARAT, India

Care Institute of Medical Sciences(CIMS) Hospital Private Limited; 🇮🇳 Ahmadabad, GUJARAT, India

DDMM Heart Institute; 🇮🇳 Kheda, GUJARAT, India

Dr. Jivaraj Mehta Smarak Health Foundation; 🇮🇳 Ahmadabad, GUJARAT, India

G.B. Pant Hospital; 🇮🇳 Delhi, DELHI, India

Ganesh Shankar Vidyarthi Memorial Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Ganga Care Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Govt. Medical College and Superspeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

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Artemis Hospital

🇮🇳Gurgaon, HARYANA, India

Dr Manjinder Sandhu

Principal investigator

91-818520234

manjinder@artemishospitals.com