drugset / Trial / NCT02740179
Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
HIV-infected individuals treated with antiretroviral medications are living longer, but have an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV population in association with with increased belly fat and altered glucose metabolism. Elevations in aldosterone hormone may also be associated with abnormal blood flow, inflammation, and coronary plaque in the heart. This study is being conducted to evaluate whether therapies to reduce the actions of aldosterone may decrease the burden and progression of heart disease in the HIV population.
Timeline
- Start
- 2017-01
- Primary completion
- 2022-03-17
- Completion
- 2022-03-17
Publications
- Background Srinivasa S, Fitch KV, Wong K, Torriani M, Mayhew C, Stanley T, Lo J, Adler GK, Grinspoon SK. RAAS Activation Is Associated With Visceral Adiposity and Insulin Resistance Among HIV-infected Patients. J Clin Endocrinol Metab. 2015 Aug;100(8):2873-82. doi: 10.1210/jc.2015-1461. Epub 2015 Jun 18.
- Murthy A, Kolossvary M, Walpert AR, Sanchez E, Abohashem S, Tawakol A, Adler GK, Grinspoon SK, Srinivasa S. Proteomic Profile After Intervention With Eplerenone Among Persons With HIV. Open Forum Infect Dis. 2026 Apr 8;13(4):ofag207. doi: 10.1093/ofid/ofag207. eCollection 2026 Apr.
- Walpert AR, Gupta M, Dunderdale CN, Haptu HH, Manandhar M, deFilippi CR, Burdo TH, Lee H, Kwong RY, Srinivasa S. Exploring the PREVENT HF score and myocardial function among persons with HIV. AIDS. 2025 Sep 1;39(11):1592-1597. doi: 10.1097/QAD.0000000000004252. Epub 2025 Jun 4.
- Srinivasa S, Walpert AR, Huck D, Thomas TS, Dunderdale CN, Lee H, Dicarli MF, Adler GK, Grinspoon SK. Coronary Microvascular Dysfunction Is Present Among Well-Treated Asymptomatic Persons With HIV and Similar to Those With Diabetes. Open Forum Infect Dis. 2024 Apr 26;11(5):ofae234. doi: 10.1093/ofid/ofae234. eCollection 2024 May.
- Srinivasa S, Abohashem S, Walpert AR, Dunderdale CN, Iyengar S, Shen G, Jerosch-Herold M, deFilippi CR, Robbins GK, Lee H, Kwong RY, Adler GK, Tawakol A, Grinspoon SK. Mineralocorticoid Receptor Antagonism by Eplerenone and Arterial Inflammation in HIV: The MIRABELLA HIV Study. JAMA Cardiol. 2024 Feb 1;9(2):189-194. doi: 10.1001/jamacardio.2023.4578.
- Thomas TS, Dunderdale C, Lu MT, Walpert AR, Shen G, Young MCH, Torriani M, Chu JT, Haptu HH, Manandhar M, Wurcel A, Adler GK, Grinspoon SK, Srinivasa S. Visceral Adiposity Index as a Measure of Cardiovascular Disease in Persons With Human Immunodeficiency Virus. Open Forum Infect Dis. 2023 Jul 24;10(8):ofad398. doi: 10.1093/ofid/ofad398. eCollection 2023 Aug.
- Srinivasa S, Walpert AR, Thomas TS, Huck DM, Jerosch-Herold M, Islam S, Lu MT, Burdo TH, deFilippi CR, Dunderdale CN, Feldpausch M, Iyengar S, Shen G, Baak S, Torriani M, Robbins GK, Lee H, Kwong R, DiCarli M, Adler GK, Grinspoon SK. Randomized Placebo-Controlled Trial to Evaluate Effects of Eplerenone on Myocardial Perfusion and Function Among Persons With Human Immunodeficiency Virus (HIV)-Results From the MIRACLE HIV Study. Clin Infect Dis. 2023 Oct 13;77(8):1166-1175. doi: 10.1093/cid/ciad310.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eplerenone | Unknown | 50 mg | Oral |