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

Part of paid clinical trials in Alexander City, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03877224
Phase
PHASE3
Status
Completed

Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Eligibility Criteria

Sex
ALL
Age
40 Years - 150 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
  • Placebo — OTHER
    Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.

Study Details

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)

Key Dates

Start date
Apr 4, 2019
Status verified
Nov 2021
Primary completion
Jul 9, 2020
Completion
Jul 9, 2020

Study Design

Enrollment
504 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Green, diamond shaped, film coated tablets 10 mg administered orally, once daily
  • Placebo Comparator: Placebo
    Green, diamond shaped, film coated tablets placebo administered orally, once daily

Primary Outcome Measure

Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 16 (Higher Scores Represent Less HF Symptom Frequency and Burden) [ Time Frame: At baseline and at week 16 or death before week 16 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Research SiteAlexander CityAlabama35010-
Research SiteFort PayneAlabama35967-
Research SiteBeverly HillsCalifornia90211-
Research SiteTorranceCalifornia90502-
Research SiteJacksonvilleFlorida32209-
Research SiteMiamiFlorida33133-
Research SiteMiamiFlorida33173-
Research SiteTuckerGeorgia30084-
Research SiteArlington HeightsIllinois60005-
Research SiteHazel CrestIllinois60429-
Research SiteMunsterIndiana46321-
Research SiteLouisvilleKentucky40205-
Research SiteBossier CityLouisiana71111-
Research SiteAnnapolisMaryland21401-
Research SiteNew BrunswickNew Jersey08901-
Research SiteRidgewoodNew Jersey07450-
Research SiteRosedaleNew York11422-
Research SiteBurlingtonNorth Carolina27215-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteCincinnatiOhio45267-
Research SiteAbingtonPennsylvania19001-
Research SiteDoylestownPennsylvania18901-
Research SitePittsburghPennsylvania15212-
Research SiteSpringTexas77380-
Research SiteSeattleWashington98101-

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By research site
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