Heart FailurePhase 4NCT04249778
Dapagliflozin at Discharge on Hospital Heart Failure Readmission
A Phase 4 study testing Dapagliflozin in people with Heart Failure and Diabetes, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Diabetes
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jul 2020to 3 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study
- Females of childbearing potential who are not using adequate contraceptive methods
- In hospice or expected life expectancy less than 6 months
- Patients with diabetic foot infection, osteomyelitis and history of amputation of lower extremities within 6 months of admission
- Patients anticipated to undergo major surgical procedures during the following 6 months
- Patients with active hematuria, urinary tract infection (UTI), or history of frequent UTIs or genital mycotic infections
- Uncontrolled atrial fibrillation or atrial flutter with a resting heart rate >110bpm documented by ECG at randomization
- Any condition that in the opinion of the investigator would contraindicate the assessment of distance walked in 6 minutes (6MWD)
- Chronic pulmonary disease, i.e. with known forced expiratory volume in the first second (FEV1) <50% requiring home oxygen, or oral steroid therapy or current hospitalization for severe chronic obstructive pulmonary disease (COPD) thought to be a primary contributor to dyspnea, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
- Patients with active history of bladder cancer
- Patients with previous history of diabetic ketoacidosis, per American Diabetes Association (ADA) criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital
Atlanta, Georgia, 30322
Tulane University
New Orleans, Louisiana, 70118
Temple University
Philadelphia, Pennsylvania, 19122
About this study
Official title: Effect of Dapagliflozin at Discharge on Hospital Re-Admissions in Patients With Acutely Decompensated Heart Failure: A Randomized Controlled Study
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.
Read the detailed description
The prevalence of both heart failure and type 2 diabetes (T2D) or prediabetes are reaching epidemic proportions globally and in the United States. More than 40% of patients with established heart failure (HF) have diabetes.
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor (SGLT2-i) indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus. Treatment with SGLT2-i has been shown to reduce both heart failure hospitalizations and mortality in patients with established heart disease. However, the time of initiation of SGLT2-i therapy has not been evaluated in patients with HF. This study will be the first trial to evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, ER visits, urgent clinic visits, and death in patients with and without T2D after hospital admission for heart failure. In addition, the impact of treatment on HF symptoms quality of life, resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be evaluated. The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of patients with heart failure.
Patients with and without diabetes who have acute decompensated heart failure (ADHF) will be randomized to take either dapagliflozin or placebo daily for 26 weeks, beginning at the time of discharge from from the hospital.
- Conditions
- Heart Failure, Diabetes
- Being tested
- Dapagliflozin, Placebo
- Keywords
- hospitalization, mortality, time of initiation of therapy, quality of life, cost-effectiveness, dapagliflozin, clinical trial, diabetes
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called FARXIGA
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.
PlaceboDrug
Participants will receive a placebo to match 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 26 weeks
Secondary outcomes (13)
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline, Week 12, Week 26
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) assesses patients' perception of their heart failure and measures the impact of heart failure symptoms. The CHQ-SAS contains 16 standardized questions that assess dyspnea during daily activities, fatigue and emotional function. Items are rated on a 7-point Likert scale ranging from 1 to 7. The total score is the mean of the item scores and higher scores indicate better quality of life.
Measured: Baseline, Week 12, Week 26
N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
The heart failure, disease-specific biomarker N-terminal (NT)-pro hormone BNP (NT-proBNP) is a non-active prohormone. Levels increase when heart failure develops or gets worse and levels reduce when heart failure is stable.
Measured: Baseline, Week 12, Week 26
6-Minute Walk Distance (6MWD)
The 6-Minute Walk Distance (6MWD) test measures the distance, in meters, that a patient can quickly walk on a flat, hard surface in a period of 6 minutes
Measured: Baseline, Week 12, Week 26
Hemoglobin A1C (HbA1c) Level
HbA1c was quantified by blood test, in participants with type 2 diabetes (T2D). Higher percentages of glycated hemoglobin on red blood cells (RBCs) indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.
Measured: Baseline, Week 12, Week 26
Weight
Weight is measured in kilograms.
Measured: Baseline,Week 12, Week 26
Systolic Blood Pressure
Systolic blood pressure is measured in millimeters of mercury (mmHg). A normal systolic blood pressure level is less than 120 mmHg.
Measured: Baseline, Week 12, Week 26
Left Atrial Diameter
The normal range for left atrial diameter is 2.0 to 4.0 centimeters (cm). The left atrium increases in size with heart conditions.
Measured: Baseline, Week 12, Week 26
Serum Magnesium
Normal levels of serum magnesium are between 1.7 and 2.3 milligrams per deciliter (mg/dL).
Measured: Baseline, Week 12, Week 26
Number of Participants Dying From Cardiovascular Reasons
The number of participants dying due to cardiovascular reasons was documented.
Measured: Up to Week 26
Number of Participants With Non-fatal Myocardial Infarction (MI)
The number of participants with non-fatal myocardial infarction (MI) was documented.
Measured: Up to Week 26
Number of Participants With Stroke
The number of participants experiencing a stroke was documented.
Measured: Up to Week 26
Number of Participants With Acute Kidney Injury
The number of participants experiencing acute kidney injury was documented.
Measured: Up to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start29 Jul 2020
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249778
- Sponsor's protocol ID
- IRB00111588
- Status last verified
- May 2024
- First submitted
- 14 Jan 2020
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results reported, will be available for sharing after de-identification, including text, tables, figures, and appendices.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin at Discharge on Hospital Re-Admissions in Patients With Acutely Decompensated Heart Failure: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04249778
- Acronym / sponsor ID
- IRB00111588
- Conditions
- Heart Failure, Diabetes
- Keywords
- hospitalization, mortality, time of initiation of therapy, quality of life, cost-effectiveness, dapagliflozin, clinical trial, diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of both heart failure and type 2 diabetes (T2D) or prediabetes are reaching epidemic proportions globally and in the United States. More than 40% of patients with established heart failure (HF) have diabetes.
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor (SGLT2-i) indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus. Treatment with SGLT2-i has been shown to reduce both heart failure hospitalizations and mortality in patients with established heart disease. However, the time of initiation of SGLT2-i therapy has not been evaluated in patients with HF. This study will be the first trial to evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, ER visits, urgent clinic visits, and death in patients with and without T2D after hospital admission for heart failure. In addition, the impact of treatment on HF symptoms quality of life, resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be evaluated. The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of patients with heart failure.
Patients with and without diabetes who have acute decompensated heart failure (ADHF) will be randomized to take either dapagliflozin or placebo daily for 26 weeks, beginning at the time of discharge from from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinPatients admitted with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily for 26 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinAlso: FARXIGADapagliflozin 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. | Drug | Dapagliflozin |
| PlaceboParticipants will receive a placebo to match 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks. | Drug | Placebo |
Primary outcome
Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death
Time frame: Up to 26 weeks
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.
13 secondary outcomes
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Time frame: Baseline, Week 12, Week 26
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
Time frame: Baseline, Week 12, Week 26
N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
Time frame: Baseline, Week 12, Week 26
6-Minute Walk Distance (6MWD)
Time frame: Baseline, Week 12, Week 26
Hemoglobin A1C (HbA1c) Level
Time frame: Baseline, Week 12, Week 26
Weight
Time frame: Baseline,Week 12, Week 26
Systolic Blood Pressure
Time frame: Baseline, Week 12, Week 26
Left Atrial Diameter
Time frame: Baseline, Week 12, Week 26
Serum Magnesium
Time frame: Baseline, Week 12, Week 26
Number of Participants Dying From Cardiovascular Reasons
Time frame: Up to Week 26
Number of Participants With Non-fatal Myocardial Infarction (MI)
Time frame: Up to Week 26
Number of Participants With Stroke
Time frame: Up to Week 26
Number of Participants With Acute Kidney Injury
Time frame: Up to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results reported, will be available for sharing after de-identification, including text, tables, figures, and appendices.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Umpierrez, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Heart Failure and Diabetes, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death (time frame: Up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.