Effect of Statin Use on Aldosterone Secretion

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Pravastatin; Simvastatin

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