The University of Texas Health Science Center at San Antonio
Who can join
Adults 18 to 80, any sex, with Heart Failure or Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cardiac Output (CO)Primary· Baseline at 0 minute before B-OH-B infusion and 360 minutes after B-OH-B infusion for Group I & II. For Group III was baseline at 0 minute and 180 minutes after infusion
Within 2 weeks after the screening visit, subjects return to the Research Institute (RII) at 7:00AM for a cardiac MRI on 3.0T MRI System (TIM, Trio, Siemens Medical Solution, Malvern, PA).
Cardiac output (CO) is measured using velocity encoded phase contrast MRI. The patient lies in the MRI scanner, and the imaging plane is positioned perpendicular to the ascending aorta where blood flow can be measured accurately. The MRI scan is synchronized with the patient's heartbeats using ECG gating. Two types of images are collected: magnitude images, which provide anatomical reference, phase images,
Baseline:before Beta-H-B infusion infusion
Group
Value
95% CI
Group I Beta-Hydroxy-Butyrate
5.02
± 0.38
Group II Beta-Hydroxy-Butyrate
4.54
± 0.28
Group III Beta-Hydroxy-Butyrate
5.93
± 0.36
After Beta-H-B infusion infusion
Group
Value
95% CI
Group I Beta-Hydroxy-Butyrate
5.10
± 0.41
Group II Beta-Hydroxy-Butyrate
5.3
± 0.22
Group III Beta-Hydroxy-Butyrate
7.16
± 0.44
Ejection Fraction (EF)Primary· Baseline at 0 minute before infusion and 360 minutes after infusion for Group I & II. Group III was baseline at 0 minute of infusion and 180 minutes after infusion
A measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each heartbeat. It's a key indicator of heart function and can help diagnose and track heart failure. A normal EF typically falls between 55% and 70%. Values below 40% are often considered indicative of heart failure.
Group
Value
95% CI
Group I Beta-Hydroxy-Butyrate
0.1
± 1.2
Group II Beta-Hydroxy-Butyrate
3.9
± 3.5
Group III Beta-Hydroxy-Butyrate
6.4
± 4.5
Left Ventricular Stroke Volume (LVSV)Primary· Baseline at 0 minute before infusion and 360 minutes after infusion for Group I & II. Group III was baseline at 0 minute of infusion and 180 minutes after infusion
Represents the amount of blood ejected from the heart's left ventricle with each heartbeat. It's a crucial indicator of cardiac function, reflecting how effectively the heart pumps blood to the body.
Group
Value
95% CI
Group I Beta-Hydroxy-Butyrate
0.3
± 1.3
Group II Beta-Hydroxy-Butyrate
9.7
± 6.4
Group III Beta-Hydroxy-Butyrate
19.4
± 6.0
Myocardial Energetics-Myocardial Glucose Uptake (MGU)Secondary· MGU after B-OH-B or NaHCO3 infusion for 6 hours at minute 360 minutes
A sub-set of participants in group II also underwent a cardiac PET study to examine the effect of hyperketonemia on Myocardial Glucose Uptake (MGU) and Myocardial Blood Flow MBF). A 20-min transmission scan was performed after exposure to a retractable 68Ge ring source to correct emission data for tissue attenuation of g photons. Then, 15O-H2O (10.5 MBq/kg) was administered intravenously through the antecubital vein catheter over 20 s, and a PET scan was performed to measure MBF. Participants underwent a 6-h b-OH-B infusion (prime dose was 1.5 mg/kg/min for 20 min followed by constant rate of
Beta -H-B infusion
Group
Value
95% CI
Group II Beta-Hydroxy-Butyrate
9.6
± 1.01
NaHCO3 infusion
Group
Value
95% CI
Group II Beta-Hydroxy-Butyrate
8.56
± 0.74
Myocardial Energetics- Myocardic Blood Flow (MBF)Secondary· MBF after B-OH-B or NaHCO3 infusion for 6 hours at 360 minutes (the results showed the difference betweenB-OH-B and NaHCO3 infusion for 6 hours)
A sub-set of participants in group II also underwent a cardiac PET study to examine the effect of hyperketonemia on Myocardial Glucose Uptake (MGU) and Myocardial Blood Flow MBF). A 20-min transmission scan was performed after exposure to a retractable 68Ge ring source to correct emission data for tissue attenuation of g photons. Then, 15O-H2O (10.5 MBq/kg) was administered intravenously through the antecubital vein catheter over 20 s, and a PET scan was performed to measure MBF. Participants underwent a 6-h b-OH-B infusion (prime dose was 1.5 mg/kg/min for 20 min followed by constant rate of
Group
Value
95% CI
Group II Beta-Hydroxy-Butyrate
0.05
± 0.10
Sponsor's own description
To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii) myocardial glucose uptake using positron emission tomography (PET) with 18F-fluoro-2-deoxy-D-glucose in type 2 diabetic patients with Class II-III New York Heart Association (NYHA).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio
Last refreshed: 29 September 2025
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