Clinical trial NCT02871687: Effect of Statin Use on Aldosterone Secretion
Official title: Effect of Statin Use on Aldosterone Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: In order to provide additional evidence regarding the effect of statin therapy on aldosterone levels, the investigators propose the following randomized, double-blinded, placebo controlled protocol in relatively healthy volunteers. The investigators will evaluate aldosterone and cortisol production in response to an angiotensin II infusion under the following test conditions: 1) placebo, 2) simvastatin therapy (lipophilic statin), and 3) pravastatin therapy (hydrophilic statin). Measurements will be made to assess the effect of both acute (single dose) and chronic (6 and 12 weeks) therapy of the two statin medications.

Eligibility criteria: Inclusion Criteria:

* Blood pressure \<140/90 mmHg and \>90/50 mmHg
* Body mass index 19-40 kg/m2
* Normal screening laboratory values for:

  i. Serum sodium, potassium, glucose, liver enzymes ii. GFR (\>60 mL/min/1.73m2) iii. A1c iv. TSH
* Normal ECG
* Negative urine HCG at screening for women who are able to become pregnant.

Exclusion Criteria:

* Any prior use of statin therapy
* History of coronary disease, diabetes, hypertension, stroke, kidney disease, thyroid disease, psychiatric illness, malignancy, preeclampsia, or illness requiring overnight hospitalization in the past 6 months
* Triglycerides \> 500, LDL \> 200
* Any prescription medication or herbal medication including oral contraceptive, excluding thyroid medications
* Unstable thyroid disease (determined by abnormal TSH)
* Pregnancy or current breastfeeding
* Alcohol intake \>12 oz per week
* Tobacco or recreational drug use

Primary outcomes:
measure: Serum aldosterone following angiotensin II infusion
timeFrame: 3 months
Secondary outcomes:
measure: 24 hour urine aldosterone
timeFrame: Baseline
measure: 24 hour urine aldosterone
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital- 221 Longwood Avenue
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jonathan Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.