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

Part of paid clinical trials in Alexander City, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03877237
Phase
PHASE3
Status
Completed

Conditions

  • Heart Failure With Reduced Ejection Fraction (HFrEF)

Eligibility Criteria

Sex
ALL
Age
18 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 Reduced Ejection Fraction (HFrEF)

Key Dates

Start date
Apr 9, 2019
Status verified
Apr 2021
Primary completion
Mar 7, 2020
Completion
Mar 7, 2020

Study Design

Enrollment
313 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 (23)

FacilityCityStateZIPSite coordinators
Research SiteAlexander CityAlabama35010-
Research SiteFairhopeAlabama36532-
Research SiteFort PayneAlabama35967-
Research SiteMobileAlabama36608-
Research SiteBeverly HillsCalifornia90211-
Research SiteTorranceCalifornia90502-
Research SiteStamfordConnecticut06905-
Research SiteMiamiFlorida33133-
Research SiteMiamiFlorida33173-
Research SiteTuckerGeorgia30084-
Research SiteMunsterIndiana46321-
Research SitePetoskeyMichigan49770-
Research SiteKansas CityMissouri64111-
Research SiteNew BrunswickNew Jersey08901-
Research SiteBuffaloNew York14215-
Research SiteNew YorkNew York10001-
Research SiteRosedaleNew York11422-
Research SiteBurlingtonNorth Carolina27215-
Research SiteAbingtonPennsylvania19001-
Research SitePittsburghPennsylvania15212-
Research SiteTullahomaTennessee37388-
Research SiteFalls ChurchVirginia22042-
Research SiteSeattleWashington98101-

Find similar trials in Alexander City, AL

By research site
Research Site· Alexander City, ALResearch Site· Fairhope, ALResearch Site· Fort Payne, ALResearch Site· Mobile, ALResearch Site· Beverly Hills, CAResearch Site· Torrance, CA

Related Studies