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NCT03877224

DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction

Last Updated: 2021-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2020-07-09

Brief Summary

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International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)

Detailed Description

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Conditions

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Heart Failure With Preserved Ejection Fraction (HFpEF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dapagliflozin

Green, diamond shaped, film coated tablets 10 mg administered orally, once daily

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Intervention Type DRUG

Placebo

Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Provision of signed informed consent prior to any study specific procedures
* Male or female, aged ≥40 years
* Established documented diagnosis of symptomatic HFpEF (NYHA functional class II-IV), which has been present for at least 8 weeks
* LVEF\>40% and evidence of structural heart disease
* Elevated NT-proBNP levels
* Patients should receive background standard of care as described below: All patients will be treated according to locally recognised guidelines on standard of care treatment for patients with HFpEF. Therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) and include (unless contraindicated or not tolerated) treatment of co morbidities (including high blood pressure, ischaemic heart disease, atrial fibrillation/flutter).
* 6MWD≥100 metres and ≤425 metres at enrolment and randomization

Exclusion Criteria

* Presence of any condition that precludes exercise testing
* 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 fibrillation/flutter, 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

150 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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United States Argentina Brazil Bulgaria Canada Denmark Italy Japan Slovakia South Africa South Korea Sweden

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.

Reference Type DERIVED

PMID: 39212948 (View on PubMed)

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.

Reference Type DERIVED

PMID: 38059368 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-003441-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D169EC00001

Identifier Type: -

Identifier Source: org_study_id

DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Dapagliflozin

Dapagliflozin

Placebo

Placebo

Interventions

Dapagliflozin

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

AstraZeneca

Responsible Party

Locations

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