Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.

Part of paid clinical trials in Fairhope, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03619213
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

Key Dates

Start date
Aug 27, 2018
Status verified
Jul 2023
Primary completion
Mar 27, 2022
Completion
Mar 27, 2022

Study Design

Enrollment
6,263 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 42.1 months ]

Locations (66)

FacilityCityStateZIPSite coordinators
Research SiteFairhopeAlabama36532-
Research SiteMobileAlabama36608-
Research SiteSheffieldAlabama35660-
Research SiteTucsonArizona85724-
Research SiteLittle RockArkansas72204-
Research SiteBeverly HillsCalifornia90211-
Research SiteLoma LindaCalifornia92357-
Research SiteLos AngelesCalifornia90073-
Research SiteStamfordConnecticut06905-
Research SiteClearwaterFlorida33756-
Research SiteMiamiFlorida33155-
Research SiteNaplesFlorida34102-
Research SiteOcalaFlorida34471-
Research SiteOrmond BeachFlorida32174-
Research SitePort CharlotteFlorida33952-
Research SiteSaint AugustineFlorida32086-
Research SiteAtlantaGeorgia30303-
Research SiteChicagoIllinois60612-
Research SiteChicagoIllinois60637-
Research SiteGurneeIllinois60031-
Research SiteAndersonIndiana46011-
Research SiteMunsterIndiana46321-
Research SiteLouisvilleKentucky40202-
Research SiteHammondLouisiana70403-
Research SiteHoumaLouisiana70360-
Research SiteMonroeLouisiana71201-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteBay CityMichigan48708-
Research SiteFlintMichigan48504-
Research SiteFlintMichigan48532-
Research SiteMinneapolisMinnesota55417-
Research SiteRochesterMinnesota55905-
Research SiteSaint PaulMinnesota55102-
Research SiteKansas CityMissouri64111-
Research SiteKansas CityMissouri64128-
Research SiteSt LouisMissouri63136-
Research SiteGreat FallsMontana59405-
Research SiteLas VegasNevada89106-
Research SiteLebanonNew Hampshire03756-
Research SiteBridgewaterNew Jersey08807-
Research SiteBuffaloNew York14215-
Research SiteNew YorkNew York10001-
Research SiteNew YorkNew York10021-
Research SiteNew YorkNew York10029-
Research SiteCharlotteNorth Carolina28277-
Research SiteGreensboroNorth Carolina27405-
Research SiteWilmingtonNorth Carolina28401-
Research SiteOklahoma CityOklahoma73134-
Research SiteAltoonaPennsylvania16601-
Research SiteDoylestownPennsylvania18901-
Research SiteProvidenceRhode Island02908-
Research SiteCharlestonSouth Carolina29425-
Research SiteRapid CitySouth Dakota57701-
Research SiteJacksonTennessee38301-
Research SiteNashvilleTennessee37212-
Research SiteTullahomaTennessee37388-
Research SiteBeaumontTexas77701-
Research SiteHumbleTexas77338-
Research SiteShermanTexas75092-
Research SiteBurlingtonVermont05401-
Research SiteFalls ChurchVirginia22042-
Research SiteLeesburgVirginia20176-
Research SiteMorgantownWest Virginia26506-
Research SiteMadisonWisconsin53705-
Research SiteMilwaukeeWisconsin53295-

Find similar trials in Fairhope, AL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Research Site· Fairhope, ALResearch Site· Mobile, ALResearch Site· Sheffield, ALResearch Site· Tucson, AZResearch Site· Little Rock, ARResearch Site· Beverly Hills, CA

Related Studies