Dapagliflozin And Pulmonary Artery Hemodynamics in Heart Failure With Reduced Ejection Fraction Patients With CardioMEMS®

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Health
Study ID
NCT04570865
Phase
PHASE4
Status
Unknown

Conditions

  • Heart Failure, Systolic

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.
  • CardioMEMS — DEVICE
    The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

Study Details

The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

Key Dates

Start date
Dec 1, 2020
Status verified
Sep 2020
Primary completion
Dec 1, 2021
Completion
Feb 1, 2022

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliglozin
    The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

Primary Outcome Measure

Effect of Dapagliflozin on pulmonary diastolic pressure from baseline to 12 weeks of therapy Secondary End Points [ Time Frame: 12 weeka ]

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps ClinicLa JollaCalifornia92037
James T Heywood, MD
858-824-5073
Melody Hermel, MD (SUB_INVESTIGATOR)
Samantha Bagsic, PhD (SUB_INVESTIGATOR)
Ruth Kuo, PharmD (SUB_INVESTIGATOR)

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