Status:
COMPLETED
Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Type 2 Diabetes Mellitus
Vascular Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Aldosterone is a significant mediator of cardiovascular injury associated with heart failure and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those of angiotensin...
Eligibility Criteria
Inclusion
- age 18-70 years
- type 2 diabetes mellitus
- with or without hypertension
Exclusion
- ischemic changes on resting electrocardiogram,
- clinical evidence of heart disease (angina, heart failure, unstable angina),cerebrovascular or peripheral vascular disease,
- significant cardiac arrhythmias,
- aortic stenosis,
- 2nd or 3rd degree atrio-ventricular block, sinus node disease, or symptomatic bradycardia,
- bronchospastic lung disease with active wheezing,
- known hypersensitivity to adenosine,
- hemoglobin A1C (HbA1c) \> 8.5%, \*
- gout (If not already taking HCTZ),
- the use of Rosiglitazone,\*\*
- estimated glomerular filtration rate (eGFR) \< 60 ml/min,
- serum potassium \> 5.0 mmol/L,
- use of potassium-sparing diuretics,\*\*
- current smoker,\*
- pregnancy,
- renal disease not related to diabetes mellitus,
- uncontrolled hypertension, systolic blood pressure (BP) \>160 mm Hg and diastolic BP \>100 mm Hg,\*
- use of cyclic hormone replacement therapy
- past intolerance of angiotensin-converting enzyme (ACE) inhibitor therapy
- other major medical illnesses. Participants with evidence of a previous myocardial infarction on the first adenosine-stimulated positron emission tomography (PET) study will be withdrawn from the study.
- Screening systolic blood pressure \< 105 mm Hg off of anti-hypertensive medications
- Participants can enroll in study and proceed with in-patient evaluations if during the run-in period adjustments of medications, diet and habits lead to improved glucose control \[equivalent to HbA1c \<8.5%, controlled hypertension and cessation of smoking.
- Participants who are currently taking these medications will not qualify for a screening visit. If medications were recently stopped by the participant's physician, he or she may be screened but the baseline assessment protocol must occur 3 months after stopping.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00865124
Start Date
September 1 2008
End Date
May 1 2014
Last Update
June 14 2017
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115