DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced Ejection Fraction
NCT ID: NCT03877237
Last Updated: 2021-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
313 participants
INTERVENTIONAL
2019-04-09
2020-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dapagliflozin
Green, diamond shaped, film coated tablets 10 mg administered orally, once daily
Dapagliflozin
Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
Placebo
Green, diamond shaped, film coated tablets placebo administered orally, once daily
Placebo
Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
Interventions
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Dapagliflozin
Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
Placebo
Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
* Male or female, aged ≥18 years
* Documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 8 weeks
* LVEF≤40%
* Elevated NT-proBNP levels
* Patients should receive background standard of care as described below: All HFrEF patients should be treated according to locally recognised guidelines on standard of care treatment with both drugs and devices, as appropriate. Guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated. Therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) before visit 1 and include (unless contraindicated or not tolerated):
* an ACE inhibitor, or ARB or sacubitril/valsartan and
* a beta-blocker and
* if considered appropriate by the patient's treating physician; a mineral corticoid receptor antagonist
* 6MWD≥100 metres and ≤425 metres at enrolment and randomization.
Exclusion Criteria
* Participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial
* Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
* Type 1 diabetes mellitus
* eGFR \<25 mL/min/1.73 m2 (CKD-EPI formula) at enrolment, unstable or rapidly progressing renal disease at time of randomisation
* Systolic BP \<95 mmHg on 2 consecutive measurements
* Systolic BP ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements
* Current acute decompensated HF or hospitalisation due to decompensated HF \<4 weeks prior to enrolment
* MI, unstable angina, coronary revascularization ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization.
* Stroke or transient ischemic attack within 12 weeks prior to enrolment.
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
* HF due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease
18 Years
150 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Alexander City, Alabama, United States
Research Site
Fairhope, Alabama, United States
Research Site
Fort Payne, Alabama, United States
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Mobile, Alabama, United States
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Beverly Hills, California, United States
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Torrance, California, United States
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Stamford, Connecticut, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Tucker, Georgia, United States
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Munster, Indiana, United States
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Petoskey, Michigan, United States
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Kansas City, Missouri, United States
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New Brunswick, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Rosedale, New York, United States
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Burlington, North Carolina, United States
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Abington, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Tullahoma, Tennessee, United States
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Falls Church, Virginia, United States
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Seattle, Washington, United States
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Blumenau, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Ajax, Ontario, Canada
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North York, Ontario, Canada
Research Site
Oshawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Stoney Creek, Ontario, Canada
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York, Ontario, Canada
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Gatineau, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Georges, Quebec, Canada
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Århus N, , Denmark
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Copenhagen, , Denmark
Research Site
Esbjerg, , Denmark
Research Site
Hellerup, , Denmark
Research Site
Hjørring, , Denmark
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Hvidovre, , Denmark
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Næstved, , Denmark
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Odense C, , Denmark
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Randers, , Denmark
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Svendborg, , Denmark
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Daito-shi, , Japan
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Kobe, , Japan
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Matsubara-shi, , Japan
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Naha, , Japan
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Osaka, , Japan
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Sayama-shi,, , Japan
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Shunan-shi, , Japan
Research Site
Takarazuka-shi, , Japan
Research Site
Lučenec, , Slovakia
Research Site
Martin, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Diepkloof, Soweto, , South Africa
Research Site
Gangwon-do, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Gothenburg, , Sweden
Research Site
Lund, , Sweden
Research Site
Östersund, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Umeå, , Sweden
Countries
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References
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Docherty KF, Buendia Lopez R, Folkvaljon F, de Boer RA, Cowie MR, Hammarstedt A, Kitzman DW, Kosiborod MN, Langkilde AM, Reicher B, Senni M, Shah SJ, Verma S, Solomon SD, McMurray JJV. Effect of Dapagliflozin on Accelerometer-Based Measures of Physical Activity in Patients With Heart Failure: An Analysis of the DETERMINE Trials. Circ Heart Fail. 2024 Oct;17(10):e012349. doi: 10.1161/CIRCHEARTFAILURE.124.012349. Epub 2024 Aug 30.
McMurray JJV, Docherty KF, de Boer RA, Hammarstedt A, Kitzman DW, Kosiborod MN, Maria Langkilde A, Reicher B, Senni M, Shah SJ, Wilderang U, Verma S, Solomon SD. Effect of Dapagliflozin Versus Placebo on Symptoms and 6-Minute Walk Distance in Patients With Heart Failure: The DETERMINE Randomized Clinical Trials. Circulation. 2024 Mar 12;149(11):825-838. doi: 10.1161/CIRCULATIONAHA.123.065061. Epub 2023 Dec 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2018-003442-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D169EC00002
Identifier Type: -
Identifier Source: org_study_id
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