Effect of Statin Use on Aldosterone Secretion

Healthy Subjects Clinical Trial

Official title:

Effect of Statin Use on Aldosterone Secretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871687
• Other study ID #: 2016P000094
• Status: Completed
• Phase: Phase 1
• Start date: April 2016
• Est. completion date: March 2021

Study information

• Verified date: September 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Simvastatin
Simvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure
• Pravastatin
Pravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure

Other:
• Placebo
Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital- 221 Longwood Avenue	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vöhringer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum aldosterone following angiotensin II infusion		3 months
Secondary	24 hour urine aldosterone		Baseline
Secondary	24 hour urine aldosterone		3 months