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NCT05139472CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
8 (actual)
First submitted
10 Nov 2021
Start date
9 Nov 2021
Primary completion date
20 Sept 2023
Lead sponsor
University of Texas Southwestern Medical Center
NCT number
NCT05139472

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 8
  • From 9 Nov 2021 to the primary completion date, 20 Sept 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous hypersensitivity or adverse reaction to SGLT-2 inhibitors
  • currently treated with SGLT-2 inhibitor

Other illness

  • chronic kidney disease with glomerular filtration rate \< 45 ml/kg/min
  • unstable coronary artery disease
  • significant arrhythmia

Lab values

  • current or prior ejection fraction \<50%

Other

  • BMI \>55 kg/m2
  • inability to exercise.

Who the study is looking for

  • adults ages 50-85
  • clinical heart failure
  • ejection fraction \> 50%

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute for Exercise and Environmental Medicine
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.