drugset / Trial / NCT02871687
Effect of Statin Use on Aldosterone Secretion
RandomizedParallel-groupDouble-blindOther
Summary
The purpose of this research protocol is to determine if the same effects are observed in vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the widely used statin class of medications on the mineralocorticoid pathway would likely have significant clinical implications on the future management of hypertension and other cardiovascular disease given the known pleiotropy of aldosterone action.
Timeline
- Start
- 2016-04
- Primary completion
- 2021-03
- Completion
- 2021-03
Publications
- Background Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vohringer PA, Jeunemaitre X, Hopkins PN, Yao TM, Williams J, Adler GK, Williams GH. Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects. Circulation. 2015 Nov 10;132(19):1825-33. doi: 10.1161/CIRCULATIONAHA.115.016759. Epub 2015 Oct 2.
- Hornik ES, Altman-Merino AE, Koefoed AW, Meyer KM, Stone IB, Green JA, Williams GH, Adler GK, Williams JS. A clinical trial to evaluate the effect of statin use on lowering aldosterone levels. BMC Endocr Disord. 2020 Jul 14;20(1):105. doi: 10.1186/s12902-020-00587-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pravastatin | Small molecule | 40 mg | — |
| Comparator | Pravastatin | Small molecule | 80 mg | — |
| Comparator | Simvastatin | Small molecule | 20 mg | — |
| Comparator | Simvastatin | Small molecule | 40 mg | — |
Indications
No indication recorded.