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Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure

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ClinicalTrials.gov Identifier: NCT00799435
Recruitment Status : Terminated (Inability to recruit adequate Sample Size who met the entry criteria)
First Posted : November 27, 2008
Results First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Aguilar, Baylor College of Medicine

November 26, 2008
November 27, 2008
August 25, 2017
September 21, 2017
September 21, 2017
July 2009
April 2012   (Final data collection date for primary outcome measure)
Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity [ Time Frame: Measured at Week 12 ]
Same as current
Complete list of historical versions of study NCT00799435 on ClinicalTrials.gov Archive Site
Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide [ Time Frame: Measured at Week 12 ]
Same as current
Not Provided
Not Provided
 
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Treatment With Glucagon-Like Peptide-1 Receptor, Exenatide, in Patients With Diabetes and Heart Failure With Normal Left Ventricular Ejection Fraction
People with type 2 diabetes experience heart failure more often than do people without diabetes. This may be due to increased stiffness in the heart as a result of diabetes. This study will examine whether exenatide, a medication used to treat diabetes, may have beneficial effects on the heart in people with type 2 diabetes and heart failure.

Diastolic heart failure is a life-threatening condition that occurs when the ventricles of the heart become stiff and do not fully relax, preventing the heart from properly filling with blood. The circulation of blood then backs up, and blood collects in the body's organs, primarily the lungs. However, people with diastolic heart failure may have a normal ejection fraction, which is a measure of the amount of blood that the heart pumps out with each heart beat. Having type 2 diabetes may increase the risk of diastolic heart failure. Also, people with both heart failure and type 2 diabetes are more likely to experience poor health and even death than are people with only heart failure. It is possible that diabetes leads to increased stiffness of the ventricles and the aorta, which is the main blood vessel into which the heart empties. Exenatide, part of a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists, is a new medication that is currently used to treat elevated blood sugar levels in people with diabetes. Some studies have shown that this class of medications may have a positive effect on the heart and blood vessels. The purpose of this study is to determine the effect that exenatide has on aortic and left ventricular stiffness in people who have type 2 diabetes and diastolic heart failure.

This 12-week study will enroll adults with type 2 diabetes and diastolic heart failure with normal ejection fraction. At a baseline study visit, participants will undergo a physical examination, blood pressure and heart rate measurements, a blood collection, an echocardiogram to obtain images of the heart, and a non-invasive test that measures blood flow in the aorta. Participants will then be randomly assigned to receive either exenatide or usual care. Participants who receive exenatide will inject the medicine twice a day for 12 weeks. At Week 4, these participants will attend a study visit to adjust the medication dosage and to report any problems, and at Week 6, study staff will follow up with participants by phone. All participants will attend a study visit at Week 12 for repeat baseline testing.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Heart Failure, Diastolic
Drug: Exenatide
5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks
Other Name: Byetta
  • No Intervention: 1
    Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
  • Experimental: 2
    Participants will receive exenatide for 12 weeks.
    Intervention: Drug: Exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
60
April 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stable New York Heart Association (NYHA) Class II-IV heart failure symptoms for at least 4 weeks before study entry
  • Diagnosis of diastolic heart failure with a normal ejection fraction
  • Admitted to the hospital with a diagnosis of heart failure in the 12 months before study entry
  • Type 2 diabetes

Exclusion Criteria:

  • Unstable angina, heart attack, coronary artery bypass surgery, or angioplasty in the 3 months before study entry
  • Angina with exertion
  • Technically inadequate echocardiogram
  • Atrial fibrillation or atrial flutter
  • Severe valvular heart disease
  • Significant kidney insufficiency (serum creatinine greater than 2.0 mg/dL or require hemodialysis)
  • Conditions that may be associated with changes in markers of fibrosis or collagen turnover (e.g., ongoing or active rheumatological disease, requiring significant anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
  • Significant history of active substance abuse
  • Type 1 diabetes
  • Type 2 diabetes requiring chronic insulin use before study entry
  • Active thiazolidinedione (TZD) use, because TZDs have been shown to worsen volume retention and may exacerbate signs and/or symptoms of heart failure
  • Pregnant or breastfeeding
  • Hypertrophic cardiomyopathy
Sexes Eligible for Study: All
30 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00799435
613
1K01HL092585 ( U.S. NIH Grant/Contract )
1K01HL092585-01 ( U.S. NIH Grant/Contract )
H-22906 ( Other Identifier: Baylor College of Medicine )
No
Not Provided
Plan to Share IPD: No
David Aguilar, Baylor College of Medicine
Baylor College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: David Aguilar, MD Baylor College of Medicine
Baylor College of Medicine
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP