Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

Part of paid clinical trials in Fairhope, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03036124
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg or 5 mg tablets given once daily, per oral use.
  • Placebo — DRUG
    Placebo matching dapagliflozin 10 mg or 5 mg.

Study Details

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction

Key Dates

Start date
Feb 8, 2017
Status verified
Aug 2020
Primary completion
Jul 17, 2019
Completion
Jul 17, 2019

Study Design

Enrollment
4,744 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Patients will be randomized 1:1 to either dapagliflozin or placebo.
  • Placebo Comparator: Placebo
    Placebo matching dapagliflozin.

Primary Outcome Measure

Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. [ Time Frame: Up to 27.8 months. ]

Locations (86)

FacilityCityStateZIPSite coordinators
Research SiteFairhopeAlabama36532-
Research SiteMobileAlabama36608-
Research SiteSheffieldAlabama35660-
Research SiteBakersfieldCalifornia93309-
Research SiteBeverly HillsCalifornia90211-
Research SiteLos AngelesCalifornia90073-
Research SitePalm SpringsCalifornia92262-
Research SiteStocktonCalifornia95204-
Research SiteTorranceCalifornia90502-
Research SiteVistaCalifornia92083-
Research SiteWilmingtonDelaware19803-
Research SiteBoynton BeachFlorida33472-
Research SiteJacksonvilleFlorida32209-
Research SiteJacksonvilleFlorida32216-
Research SiteLake WorthFlorida33461-
Research SiteMiamiFlorida33125-
Research SiteMiamiFlorida33155-
Research SiteNaplesFlorida34102-
Research SiteNew Smyrna BeachFlorida32169-
Research SitePembroke PinesFlorida33024-
Research SitePort CharlotteFlorida33952-
Research SiteSaint AugustineFlorida32086-
Research SiteWellingtonFlorida33449-
Research SiteAtlantaGeorgia30303-
Research SiteCummingGeorgia30041-
Research SiteTuckerGeorgia30084-
Research SiteHazel CrestIllinois60429-
Research SiteJerseyvilleIllinois62052-
Research SitePeoriaIllinois61614-
Research SiteLouisvilleKentucky40205-
Research SiteAlexandriaLouisiana71301-
Research SiteChalmetteLouisiana70043-
Research SiteBangorMaine04401-
Research SiteBaltimoreMaryland21120-
Research SiteBaltimoreMaryland21228-
Research SiteColumbiaMaryland21044-
Research SiteBostonMassachusetts02114-
Research SiteHaverhillMassachusetts01830-
Research SiteFlintMichigan48504-
Research SiteFlintMichigan48532-
Research SiteLansingMichigan48910-
Research SiteMinneapolisMinnesota55407-
Research SiteMinneapolisMinnesota55417-
Research SiteTupeloMississippi38801-
Research SiteKansas CityMissouri64111-
Research SiteSt LouisMissouri63128-
Research SiteGreat FallsMontana59405-
Research SiteGrand IslandNebraska68803-
Research SiteLincolnNebraska68526-
Research SiteOmahaNebraska68105-
Research SiteLas VegasNevada89128-
Research SiteBridgewaterNew Jersey08807-
Research SiteNew BrunswickNew Jersey08901-
Research SiteSomersetNew Jersey08873-
Research SiteBuffaloNew York14203-
Research SiteBuffaloNew York14215-
Research SiteCortlandt ManorNew York10567-
Research SiteNew YorkNew York10001-
Research SiteOrchard ParkNew York14127-
Research SitePoughkeepsieNew York12601-
Research SiteRosedaleNew York11422-
Research SiteThe BronxNew York10459-
Research SiteBurlingtonNorth Carolina27215-
Research SiteClevelandOhio44106-6010-
Research SiteColumbusOhio43210-
Research SiteAltoonaPennsylvania16602-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15212-
Research SitePittsburghPennsylvania15240-
Research SiteRapid CitySouth Dakota57701-
Research SiteKnoxvilleTennessee37912-
Research SiteMemphisTennessee38104-
Research SiteNashvilleTennessee37212-
Research SiteTullahomaTennessee37388-
Research SiteBeaumontTexas77702-
Research SiteDallasTexas75231-
Research SiteDallasTexas75246-
Research SiteHoustonTexas77002-
Research SiteKingwoodTexas77339-
Research SiteSan AntonioTexas78234-
Research SiteTylerTexas75701-
Research SiteFarmingtonUtah84025-
Research SiteFalls ChurchVirginia22042-
Research SiteRichmondVirginia23298-
Research SiteSeattleWashington98101-
Research SiteSeattleWashington98195-

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