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| Sponsor: | Brigham and Women's Hospital |
|---|---|
| Collaborator: |
National Institutes of Health (NIH) |
| Information provided by: | Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00865124 |
Purpose
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:
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus Vascular Disease |
Drug: Spironolactone Drug: hydrochlorothiazide + potassium Other: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease |
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
MR blockade (Spironolactone)
|
Drug: Spironolactone
25 mg daily
|
|
Active Comparator: 2
hydrochlorothiazide + potassium
|
Drug: hydrochlorothiazide + potassium
12.5 mg hydrochlorothiazide daily plus 10mEq potassium
|
|
Placebo Comparator: 3
placebo capsule
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Other: placebo
placebo capsule
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
other major medical illnesses. Subjects with evidence of ischemia on the first adenosine-stimulated PET study will be withdrawn from the study.
Contacts and Locations| Contact: Lindsay Kneen | 617-732-6870 | lkneen@partners.org |
| Contact: Gail K Adler, MD, PhD | 617-732-8742 ext 15899 | gadler@partners.org |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Gail K Adler, MD, PhD | |
| Sub-Investigator: Rajesh Garg, MD | |
| Sub-Investigator: Raymond Y Kwong, MD | |
| Sub-Investigator: Marcelo F Di Carli, MD | |
| Sub-Investigator: Marie Gerhard-Herman, M.D. | |
| Principal Investigator: | Gail K Adler, MD, PhD | Brigham and Women's Hospital |
More Information
| Responsible Party: | Gail K. Adler, MD, PhD, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00865124 History of Changes |
| Other Study ID Numbers: | 2007-P-000564, 1 R01HL 087060-01A2 |
| Study First Received: | March 17, 2009 |
| Last Updated: | June 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hydrochlorothiazide Spironolactone Mineralocorticoids Diuretics Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Aldosterone Antagonists Hormone Antagonists |