Chronic Heart Failure With Reduced Systolic FunctionPhase 4DEFINE-HFNCT02653482
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
A Phase 4 study testing Dapagliflozin in people with Chronic Heart Failure With Reduced Systolic Function, run by Saint Luke's Health System at 25 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function. Read more about this study
- Who is it for?
- Ages 19 to 119 years
- Conditions the study is for
- Chronic Heart Failure With Reduced Systolic Function
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 25 sitesUnited States
- Study dates
- 3 Mar 2016to 28 Jun 2019
- 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 19 to 119 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of New York Heart Association (NYHA) Class II or Class III heart failure (left ventricular ejection fraction ≤40% due to either ischemic or non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to enrollment
- No change in diuretic management for at least 1 week prior to enrollment
- Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 400 pg/mL at enrollment
Who cannot join
- History of type 1 diabetes
- Estimated glomerular filtration rate (eGFR) < 30 at enrollment
- Hospitalization for heart failure within the 30 days prior to enrollment
- Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within the 30 days prior to enrollment
- Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
- Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy) within the 90 days after enrollment
- Patients who are volume depleted based upon physical examination at the time of screening or randomization
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Emory University
Atlanta, Georgia, 30303
University of Maryland
Baltimore, Maryland, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27705
NorthShore University HealthSystem Research Institute
Evanston, Illinois, 60201
Northwestern University
Evanston, Illinois, 60208
Heart Group of the Eastern Shore
Fairhope, Alabama, 36532
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Freeman Health System
Joplin, Missouri, 64804
Truman Medical Center
Kansas City, Missouri, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
University of Southern Califiornia
Los Angeles, California, 90032
Vanderbilt University
Nashville, Tennessee, 37232
Eastern Nephrology Associates
New Bern, North Carolina, 28562
New York University
New York, New York, 10016
Advocate Health and Hospitals
Oakbrook Terrace, Illinois, 60181
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Charlotte Heart Group Research Center
Port Charlotte, Florida, 33952
Mayo Clinic
Rochester, Minnesota, 55905
St. Francis Hospital
Roslyn, New York, 11576
Washington University
St Louis, Missouri, 63110
About this study
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.
Read the detailed description
A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (BNP and NTproBNP), symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.
- Being tested
- Dapagliflozin, Dapagliflozin matching placebo
- Keywords
- heart failure, dapagliflozin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Farxiga
Dapagliflozin matching placeboDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Active comparator | Dapagliflozin 10 mg daily Receives: Drug: Dapagliflozin |
| Dapagliflozin matching placebo | Placebo comparator | Dapagliflozin matching placebo 10 mg daily Receives: Drug: Dapagliflozin matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP).
Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP).
Measured: Average of Week 6 and Week 12
Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks
A composite of the percentage of patients that achieved a meaningful improvement in health status (≥5-point increase in average of 6- and 12-week KCCQ-OS) or NT-proBNP (≥20% decrease in average of 6- and 12-week NT-proBNP).
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.
Measured: Average of Week 6 and Week 12
Secondary outcomes (9)
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
Percentage of patients with a ≥ 5-point increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) as measured at Week 6 and Week 12.
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.
Measured: Baseline to Week 6 and Week 12
Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
Percentage of patients with a ≥ 20% decrease in NTproBNP as measured at Week 6 and Week 12.
Measured: Baseline to Week 6 and Week 12
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.
Measured: Average of Week 6 and Week 12
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks.
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) over 12 weeks as measured at Week 6 and Week 12.The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.
Measured: Baseline to Week 6 and Week 12
Change in 6 Minute Walk Score Over 12 Weeks.
Change in 6 minute walk score over 12 weeks as measured at Week 6 and Week 12. The 6 minute walk 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 to Week 6 and Week 12
Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks.
Change in BNP over 12 weeks as measured at Week 6 and Week 12 as measured at Week 6 and Week 12.
Measured: Baseline to Week 6 and Week 12
Change in Hemoglobin A1c (HbA1c) Over 12 Weeks.
Change in HbA1c over 12 weeks as measured at Week 6 and Week 12.
Measured: Baseline to Week 6 and Week 12
Change in Weight Over 12 Weeks
Change in weight over 12 weeks as measured at Week 6 and Week 12.
Measured: Baseline to Week 6 and Week 12
Change in Systolic Blood Pressure Over 12 Weeks
Change in systolic blood pressure over 12 weeks as measured at Week 6 and Week 12.
Measured: Baseline to Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study start3 Mar 2016
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart Failure With Reduced Systolic FunctionStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikhail Kosiborod, MD, Study chair, Saint Luke's Mid America Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653482
- Sponsor's protocol ID
- D1690C00032
- Acronym
- DEFINE-HF
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2016
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nassif ME, Windsor SL, Tang F, Khariton Y, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Austin B, Drazner MH, Fong MW, Givertz MM, Gordon RA, Jermyn R, Katz SD, Lamba S, Lanfear DE, LaRue SJ, Lindenfeld J, Malone M, Margulies K, Mentz RJ, Mutharasan RK, Pursley M, Umpierrez G, Kosiborod M. Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial. Circulation. 2019 Oct 29;140(18):1463-1476. doi: 10.1161/CIRCULATIONAHA.119.042929. Epub 2019 Sep 16.
PubMed 31524498Selvaraj S, Patel S, Sauer AJ, McGarrah RW, Jones P, Kwee LC, Windsor SL, Ilkayeva O, Muehlbauer MJ, Newgard CB, Borlaug BA, Kitzman DW, Shah SJ, Margulies KB, Husain M, Inzucchi SE, McGuire DK, Lanfear DE, Javaheri A, Umpierrez G, Mentz RJ, Sharma K, Kosiborod MN, Shah SH. Metabolic Effects of the SGLT2 Inhibitor Dapagliflozin in Heart Failure Across the Spectrum of Ejection Fraction. Circ Heart Fail. 2024 Nov;17(11):e011980. doi: 10.1161/CIRCHEARTFAILURE.124.011980. Epub 2024 Oct 18.
PubMed 39421941Nassif ME, Windsor SL, Gosch K, Borlaug BA, Husain M, Inzucchi SE, Kitzman DW, McGuire DK, Pitt B, Scirica BM, Shah SJ, Umpierrez G, Austin BA, Lamba S, Khumri T, Sharma K, Kosiborod MN. Dapagliflozin Improves Heart Failure Symptoms and Physical Limitations Across the Full Range of Ejection Fraction: Pooled Patient-Level Analysis From DEFINE-HF and PRESERVED-HF Trials. Circ Heart Fail. 2023 Jul;16(7):e009837. doi: 10.1161/CIRCHEARTFAILURE.122.009837. Epub 2023 May 19.
PubMed 37203441Selvaraj S, Fu Z, Jones P, Kwee LC, Windsor SL, Ilkayeva O, Newgard CB, Margulies KB, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Lanfear DE, Nassif ME, Javaheri A, Mentz RJ, Kosiborod MN, Shah SH; DEFINE-HF Investigators. Metabolomic Profiling of the Effects of Dapagliflozin in Heart Failure With Reduced Ejection Fraction: DEFINE-HF. Circulation. 2022 Sep 13;146(11):808-818. doi: 10.1161/CIRCULATIONAHA.122.060402. Epub 2022 May 23.
PubMed 35603596Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.
PubMed 31081589
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02653482
- Acronym / sponsor ID
- DEFINE-HF / D1690C00032
- Keywords
- heart failure, dapagliflozin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.
Detailed description
A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (BNP and NTproBNP), symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Active comparator | Drug: DapagliflozinDapagliflozin 10 mg daily |
| Dapagliflozin matching placebo | Placebo comparator | Drug: Dapagliflozin matching placeboDapagliflozin matching placebo 10 mg daily |
Who may qualify
- Ages
- 19 to 119 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of New York Heart Association (NYHA) Class II or Class III heart failure (left ventricular ejection fraction ≤40% due to either ischemic or non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to enrollment
- No change in diuretic management for at least 1 week prior to enrollment
- Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 400 pg/mL at enrollment
Key exclusion criteria (7 listed)
- History of type 1 diabetes
- Estimated glomerular filtration rate (eGFR) < 30 at enrollment
- Hospitalization for heart failure within the 30 days prior to enrollment
- Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within the 30 days prior to enrollment
- Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
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: Farxiga | Drug | Dapagliflozin |
| Dapagliflozin matching placeboAlso: Placebo | Drug | Dapagliflozin matching placebo |
Primary outcome
Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP).
Time frame: Average of Week 6 and Week 12
Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP).
Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks
Time frame: Average of Week 6 and Week 12
A composite of the percentage of patients that achieved a meaningful improvement in health status (≥5-point increase in average of 6- and 12-week KCCQ-OS) or NT-proBNP (≥20% decrease in average of 6- and 12-week NT-proBNP). The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.
9 secondary outcomes
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
Time frame: Baseline to Week 6 and Week 12
Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
Time frame: Baseline to Week 6 and Week 12
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
Time frame: Average of Week 6 and Week 12
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks.
Time frame: Baseline to Week 6 and Week 12
Change in 6 Minute Walk Score Over 12 Weeks.
Time frame: Baseline to Week 6 and Week 12
Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks.
Time frame: Baseline to Week 6 and Week 12
Change in Hemoglobin A1c (HbA1c) Over 12 Weeks.
Time frame: Baseline to Week 6 and Week 12
Change in Weight Over 12 Weeks
Time frame: Baseline to Week 6 and Week 12
Change in Systolic Blood Pressure Over 12 Weeks
Time frame: Baseline to Week 6 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31524498Nassif ME, Windsor SL, Tang F, Khariton Y, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Austin B, Drazner MH, Fong MW, Givertz MM, Gordon RA, Jermyn R, Katz SD, Lamba S, Lanfear DE, LaRue SJ, Lindenfeld J, Malone M, Margulies K, Mentz RJ, Mutharasan RK, Pursley M, Umpierrez G, Kosiborod M. Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial. Circulation. 2019 Oct 29;140(18):1463-1476. doi: 10.1161/CIRCULATIONAHA.119.042929. Epub 2019 Sep 16.
- Derived from this study: PubMed 39421941Selvaraj S, Patel S, Sauer AJ, McGarrah RW, Jones P, Kwee LC, Windsor SL, Ilkayeva O, Muehlbauer MJ, Newgard CB, Borlaug BA, Kitzman DW, Shah SJ, Margulies KB, Husain M, Inzucchi SE, McGuire DK, Lanfear DE, Javaheri A, Umpierrez G, Mentz RJ, Sharma K, Kosiborod MN, Shah SH. Metabolic Effects of the SGLT2 Inhibitor Dapagliflozin in Heart Failure Across the Spectrum of Ejection Fraction. Circ Heart Fail. 2024 Nov;17(11):e011980. doi: 10.1161/CIRCHEARTFAILURE.124.011980. Epub 2024 Oct 18.
- Derived from this study: PubMed 37203441Nassif ME, Windsor SL, Gosch K, Borlaug BA, Husain M, Inzucchi SE, Kitzman DW, McGuire DK, Pitt B, Scirica BM, Shah SJ, Umpierrez G, Austin BA, Lamba S, Khumri T, Sharma K, Kosiborod MN. Dapagliflozin Improves Heart Failure Symptoms and Physical Limitations Across the Full Range of Ejection Fraction: Pooled Patient-Level Analysis From DEFINE-HF and PRESERVED-HF Trials. Circ Heart Fail. 2023 Jul;16(7):e009837. doi: 10.1161/CIRCHEARTFAILURE.122.009837. Epub 2023 May 19.
- Derived from this study: PubMed 35603596Selvaraj S, Fu Z, Jones P, Kwee LC, Windsor SL, Ilkayeva O, Newgard CB, Margulies KB, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Lanfear DE, Nassif ME, Javaheri A, Mentz RJ, Kosiborod MN, Shah SH; DEFINE-HF Investigators. Metabolomic Profiling of the Effects of Dapagliflozin in Heart Failure With Reduced Ejection Fraction: DEFINE-HF. Circulation. 2022 Sep 13;146(11):808-818. doi: 10.1161/CIRCULATIONAHA.122.060402. Epub 2022 May 23.
- Derived from this study: PubMed 31081589Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.
- Drug information for dapagliflozinLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mikhail Kosiborod, MD study chair
Saint Luke's Mid America Heart Institute
25 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 Chronic Heart Failure With Reduced Systolic Function, run by Saint Luke's Health System at 25 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 3 inclusion and 7 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 1 Dec 2021). 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?
Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). (time frame: Average of Week 6 and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653482, which also lists 5 linked publications.
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 21 Apr 2022.