Dapagliflozin at Discharge on Hospital Heart Failure Readmission

NCT04249778 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00111588
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, emergency room (ER) visits, urgent clinic visits, and death in patients with and without type 2 diabetes (T2D) after hospital admission for heart failure.

Conditions

Heart Failure; Diabetes

Keywords

hospitalization; mortality; time of initiation of therapy; quality of life; cost-effectiveness; dapagliflozin; clinical trial; diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death

  The number of participants meeting criteria for a composite of hospital admissions, emergency department visits, urgent clinic visits for heart failure and death after admission with acute decompensated heart failure (ADHF) was determined.

  Up to 26 weeks

Secondary Outcomes (13)

• Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

  Baseline, Week 12, Week 26

• Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score

  Baseline, Week 12, Week 26

• N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels

  Baseline, Week 12, Week 26

• 6-Minute Walk Distance (6MWD)

  Baseline, Week 12, Week 26

• Hemoglobin A1C (HbA1c) Level

  Baseline, Week 12, Week 26

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Patients admitted with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily for 26 weeks.

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Patients admitted with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily for 26 weeks.

Drug: Placebo

Interventions

Dapagliflozin DRUG

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Participants will receive 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.

Also known as: FARXIGA

Dapagliflozin

Placebo DRUG

Participants will receive a placebo to match 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between the ages of 18 and 90 years, with ADHF, and New York Heart Association (NYHA) class II, III, or IV symptoms discharged after hospital admission with a clinical diagnosis ADHF
• Elevated natriuretic peptide tests measure levels of BNP (NT-pro-BNP) ≥300 pg/ml or B-type natriuretic peptide (BNP) ≥100 pg/ml on admission
• Interpretable echocardiogram during hospital admission (or within 12 months prior to index hospitalization)
• Blood glucose level \<400 mg/dL without evidence of diabetic ketoacidosis (serum bicarbonate \<18 milliequivalent (mEq)/L or positive serum or urinary ketones), in patients with T2D

You may not qualify if:

• Age \< 18 or \> 90 years
• Subjects with a history of type 1 diabetes
• Treatment with thiazolidinediones (TZDs) or SGLT2-i during the past 3 months of admission
• Recurrent episodes of severe hypoglycemia or hypoglycemic unawareness
• History of recurrent HF admissions considered to be due to non-compliance (evaluated by the research staff for participation)
• Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 3 times upper limit of normal
• Patients with impaired renal function (GFR \< 25 ml/min)
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• Patients on ventricular assist devices (VADs)
• History of heart transplant or listed for heart transplant
• History of cardiac surgery (within 90 days prior to enrollment) or planned cardiac interventions within the following 6 months, including percutaneous coronary intervention (PCI), ablation, cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator (ICD)
• HF due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valvular diseases, hypertrophic cardiomyopathy, or congenital heart disease
• History of SGLT2-i allergy
• Systolic blood pressure \< 100 mmHg
• Uncontrolled hypertension, defined as a systolic blood pressure \> 200 mmHg at randomization

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Tulane University

New Orleans, Louisiana, 70118, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This study occurred during the Coronavirus Disease 2019 (COVID-19) pandemic resulting in many participants lost to follow-up.

Results Point of Contact

• Title: Dr. Guillermo E. Umpierrez
• Organization: Emory University

geumpie@emory.edu

(404) 778-1663

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 31, 2020
• Study Start: July 29, 2020
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: June 14, 2024
• Results First Posted: March 29, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing beginning 6 months after publication of results from this study and ending 5 years after publication.
• Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal. Proposals should be directed to geumpie@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (3)