Heart Failure, Congestive Clinical Trial
Official title:
Effect of Sitagliptin on Insulin Resistance and Myocardial Metabolism in Heart Failure
This study will investigate the effects of sitagliptin, a medicine commonly used to treat
type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure
which is not due to heart attacks. We hope to determine whether improving the heart's
ability to use glucose in the blood may help improve the function of the heart as well. If
so, this may suggest that even people who do not have frank diabetes but who do have heart
failure may benefit from using this medication.
This study will also investigate the effect of sitagliptin on the body's use of sugar, and
of the effect of sitagliptin on blood flow to the heart.
Screening:
Patients will be screened based on existing clinic information regarding NYHA class (New
York Heart Association functional class) and heart failure characteristics. Patients will be
approached in clinic after completing clinical care for that visit regarding participation
in this trial.
If the patient agrees to participate, informed consent will be obtained at this time.
At enrollment:
Patients will be queried as to whether they have undergone previous nuclear medicine scans
in the previous year in order to ensure that they do not exceed current standards for total
annual radiation exposure.
Undergo a baseline combined 18-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)
PET/13N-NH3 PET/CT to assess the heart's ability to utilize blood sugar and coronary blood
flow. This will take approximately 3-4 hours. This is a nuclear medicine procedure which is
commonly used to assess myocardial viability as well as global heart function. It involves
injection of a radioisotope-labeled tracers (18-FDG and 13N-NH3) intravenously followed by
the measurement of myocardial uptake using a tomographic scanner. Venous blood samples
performed during a 75g oral glucose load during the 18-FDG portion will assist with
quantitation of myocardial glucose uptake and of measurements of insulin sensitivity.
Perfusion (13N-NH3) images will be repeated during infusion of adenosine 0.14 mg/kg/min in
order to assess coronary flow reserve. A computed tomography scan will be performed at the
same time as the baseline PET scan for attenuation correction. Blood draws to measure
changes in fasting insulin, blood sugar, lipid profile, and ADMA levels. Approximately 45 cc
or 3 tablespoons of blood will be drawn and saved for possible future analysis.
18-FDG/13N-NH3 PET scans are routinely performed on patients with ischemic heart disease.
While this study will use standard protocol for these examinations, they are not currently
part of standard of care for nonischemic heart failure. However, they are important in
testing the hypothesis of this study.
3) Begin sitagliptin 100 mg daily for four weeks. If calculated creatinine clearance is
30-49 cc/min by the Cockcroft-Gault formula, sitagliptin dose will be reduced to 50 mg daily
for four weeks as per manufacturer guidelines. There will be no placebo arm. This will be an
open-label study. Patients will be advised regarding potential side effects to prompt
notification of study personnel. They will be instructed to contact the investigators for
any concerns or evidence of adverse effects.
4) At four weeks: Repeat FDG/NH3 PET as above to compare to pretreatment scan. This will
take approximately 3-4 hours. Blood draws to measure changes in fasting insulin, blood
sugar, lipid profile, and ADMA (asymmetrical dimethylarginine) levels. Approximately 45 cc
or 3 tablespoons of blood will be drawn and saved for possible future analysis.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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