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

NCT05139472 | Completed Phase 4 FDA Drug

• 1 other identifier: STU 2018-0311
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure with Preserved Ejection Fraction; Heart Failure, Diastolic; Diabetes Mellitus

Keywords

Exercise; Invasive Exercise Testing; SGLT-2 Inhibitors

Outcome Measures

Primary Outcomes (2)

• Peak Oxygen Uptake

  Peak VO2 measured on maximal exercise test

  12 weeks

• Peak Pulmonary Capillary Wedge Pressure (PCWP)

  Peak PCWP, measured at end-expiration, at the end of maximal exercise test

  12 weeks

Secondary Outcomes (9)

• Primary Endpoints after single dose of empagliflozin

  1 hour

• Cardiac Output at Rest and During Exercise

  12 weeks

• Stroke Volume at Rest and During Exercise

  12 weeks

• Right Atrial Pressure at Rest and During Exercise

  12 weeks

• Pulmonary Capillary Wedge Pressure at Rest and During Submaximal Exercise

  12 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

This arm of the study will take 10 mg empagliflozin daily for 12 weeks

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 10 MG DRUG

Daily Empagliflozin

Treatment Arm

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previous hypersensitivity or adverse reaction to SGLT-2 inhibitors
• currently treated with SGLT-2 inhibitor
• current or prior ejection fraction \<50%
• chronic kidney disease with glomerular filtration rate \< 45 ml/kg/min
• unstable coronary artery disease
• significant arrhythmia
• BMI \>55 kg/m2
• inability to exercise.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Boehringer Ingelheim: collaborator

Study Sites (2)

Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Diabetes Mellitus; Motor Activity

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Single arm, open label trial

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 1, 2021
• Study Start: November 9, 2021
• Primary Completion: September 20, 2023
• Study Completion: February 19, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)