Empagliflozin Impact on Hemodynamics in Patients With Heart Failure

Part of paid clinical trials in Los Angeles, California.

Sponsor
Saint Luke's Health System
Study ID
NCT03030222
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 119 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device (a wireless hemodynamic monitoring system) implanted for non-study related clinical reasons.

Key Dates

Start date
Jul 5, 2017
Status verified
Nov 2021
Primary completion
Mar 10, 2020
Completion
Mar 10, 2020

Study Design

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

Arms

  • Active Comparator: Empagliflozin
    Empagliflozin 10 mg tab, once daily, for 12 weeks
  • Placebo Comparator: Placebo
    Empagliflozin matching placebo oral tablet, once daily for 12 weeks

Primary Outcome Measure

Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo [ Time Frame: Baseline to average between Weeks 8-12 ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-
First Coast Cardiovascular InstituteJacksonvilleFlorida32256-
NorthShore University Health System Research InstituteEvanstonIllinois60201-
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303-
St. Francis HospitalRoslynNew York11576-
Ohio State UniversityColumbusOhio43210-
Sanford ResearchSioux FallsSouth Dakota57104-
Austin Heart Clinical ResearchAustinTexas78756-
Baylor College of MedicineHoustonTexas77030-
Sentara Cardiovascular Research InstituteNorfolkVirginia23507-

Find similar trials in Los Angeles, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
University of Southern California· Los Angeles, CAFirst Coast Cardiovascular Institute· Jacksonville, FLNorthShore University Health System Research Institute· Evanston, ILCentraCare Heart and Vascular Center· Saint Cloud, MNSt. Francis Hospital· Roslyn, NYOhio State University· Columbus, OH

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