Impact of Empagliflozin on Functional Capacity in Heart Failure with Preserved Ejection Fraction

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05139472
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors generally and empagliflozin specifically have shown cardiovascular benefits in patients with heart failure (HF), but the underlying mechanisms remain unclear. Empagliflozin use resulted in lower pulmonary artery diastolic pressures in patients with HF, suggesting a beneficial diuretic effect. Other potential mechanisms include increased blood volume, decreased blood pressure, and changes in sympathetic and neuro-hormonal activation. This study is a single-arm, open label, prospective interventional study of 8 subjects with heart failure with preserved ejection fraction (HFpEF). Before and after 12 weeks of daily empagliflozin, participants with undergo comprehensive invasive exercise testing with a right heart catheter. Our goal is to evaluate the effects of empagliflozin on fitness, assessed by peak VO2, and peak left ventricular filling pressure, assessed by pulmonary capillary pressure at peak exercise.

Key Dates

Start date
Nov 9, 2021
Status verified
Sep 2024
Primary completion
Sep 20, 2023
Completion
Feb 19, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    This arm of the study will take 10 mg empagliflozin daily for 12 weeks

Primary Outcome Measure

Peak Oxygen Uptake [ Time Frame: 12 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Institute for Exercise and Environmental MedicineDallasTexas75231-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Institute for Exercise and Environmental Medicine· Dallas, TXUniversity of Texas Southwestern Medical Center· Dallas, TX

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