Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Vascular Disease
Intervention: Spironolactone (Drug); hydrochlorothiazide + potassium (Drug); placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s):
Gail K Adler, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Overall contact:
Gail K Adler, MD, PhD, Phone: 617-732-8742, Ext: 15899, Email: gadler@partners.org
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 converting enzyme inhibitors or angiotensin II receptor blockers. This study
will test the hypothesis that MR antagonists exert beneficial cardiovascular effects,
specifically by decreasing vascular injury and improving vascular function. A randomized,
double-blind study will be conducted, in which subjects with Type 2 Diabetes Mellitus will
undergo a series of assessments to test heart, blood vessel, and kidney function at
baseline, and after 2 and 6 months of treatment with one of the following drugs:
1. spironolactone
2. hydrochlorothiazide plus potassium
3. placebo.
Clinical Details
Official title: Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Primary outcome: MR blockade improves coronary circulatory and cardiac diastolic function in individuals with T2DM
Secondary outcome: MR blockade improves renovascular function in subjects with T2DM
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age 18-64 years
- type 2 diabetes mellitus
- hypertension
- healthy volunteers
Exclusion Criteria:
- 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 > 8. 0%
- use of vitamin A, C, E, or antioxidants
- GFR < 50 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 BP > 160 mmHg and diastolic BP > 100mmHg
- use of hormone replacement therapy
- other major medical illness. Subjects with evidence of ischemia on the first
adenosine-stimulated PET study will be withdrawn from the study
Locations and Contacts
Gail K Adler, MD, PhD, Phone: 617-732-8742, Ext: 15899, Email: gadler@partners.org
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Gail K Adler, MD, PhD, Principal Investigator
Rajesh Garg, MD, Sub-Investigator
Raymond Y Kwong, MD, Sub-Investigator
Marcelo F Di Carli, MD, Sub-Investigator
Marie Gerhard-Herman, M.D., Sub-Investigator
Additional Information
Starting date: September 2008
Ending date: April 2013
Last updated: September 15, 2009
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