Search / Trial NCT06229678

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Ketones Cardiovascular Benefit

ClinConnect Summary

This clinical trial is investigating how higher levels of ketones in the blood can affect heart function in people with type 2 diabetes and heart failure. Specifically, the study looks at patients who have a reduced ability of their heart to pump blood effectively. By starting a specific type of medication called an SGLT2 inhibitor, the researchers hope to see if the ketones can provide extra energy for the heart, which could help improve its performance.

To participate in this trial, you need to be between 18 and 80 years old, have type 2 diabetes, and be experiencing certain levels of heart failure. Other requirements include having a stable weight, being on certain heart medications, and not having any severe heart or health issues. If you join the study, you’ll be monitored closely to see how your heart responds to the treatment. This trial is currently recruiting participants, and it aims to help improve treatment options for individuals facing these challenging health conditions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Type 2 Diabetes Mellitus
  • Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
  • Age 18-80 years
  • BMI 23-38 kg/m2
  • Glycated hemoglobin (HbA1c) 5.5-10%
  • Blood Pressure (BP) ≤ 145/85 mmHg
  • Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
  • Stable dose of guideline-directed medications for heart failure
  • Stable body weight (±4 pounds) over the last 3 months
  • Exclusion Criteria:
  • Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
  • Resting heart rate \>120 bpm
  • Systolic BP\>180mmHg and/or diastolic BP \>100mmHg
  • Resting percentage of blood oxygen saturation (SpO2) \< 85%
  • Physical disability preventing safe performance of the exercise protocol.

Trial Officials

Ralph DeFronzo, MD

Principal Investigator

University of Texas Health Science Center San Antonio

About The University Of Texas Health Science Center At San Antonio

The University of Texas Health Science Center at San Antonio (UT Health San Antonio) is a leading academic medical institution dedicated to advancing health through education, research, and patient care. As a prominent sponsor of clinical trials, UT Health San Antonio focuses on innovative medical research aimed at improving health outcomes across diverse populations. With a commitment to excellence, the institution fosters collaboration among its multidisciplinary teams to explore cutting-edge therapies and interventions. Through rigorous scientific inquiry and ethical practices, UT Health San Antonio strives to make meaningful contributions to the field of medicine and enhance the quality of life for patients.

Locations

San Antonio, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0