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Effect of Statin Use on Aldosterone Secretion

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02871687
Collaborator
(none)
103
Enrollment
1
Location
3
Arms
59
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Effect of Statin Use on Aldosterone Secretion
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo prepared by Investigational Drug Services at Brigham and Women's Hospital

Other: Placebo
Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital
Active Comparator: Simvastatin

Subjects in the simvastatin arm will receive simvastatin 20 mg daily for 6 weeks before having their lipids checked. If their LDL-c decreases by less than 35% from screening, then the dose of simvastatin is increased to 40 mg daily for the following 6 weeks.

Drug: Simvastatin
Simvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure
Other Names:
  • Zocor

    		•
    Active Comparator: Pravastatin

    Subjects in the pravastatin arm will receive pravastatin 40 mg daily for 6 weeks before having their lipids checked. If their LDL-c decreases by less than 35% from screening, then the dose of pravastatin is increased to 80 mg daily for the following 6 weeks.

    Drug: Pravastatin
    Pravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure
    Other Names:
  • Pravachol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum aldosterone following angiotensin II infusion [3 months]

    Secondary Outcome Measures

    1. 24 hour urine aldosterone [Baseline]

    2. 24 hour urine aldosterone [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Blood pressure <140/90 mmHg and >90/50 mmHg

    • Body mass index 19-40 kg/m2

    • Normal screening laboratory values for:

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital- 221 Longwood Avenue Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Jonathan Williams, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jonathan S. Williams, MD, MMSc, Associate Physician, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT02871687
    Other Study ID Numbers:
    • 2016P000094
    First Posted:
    Aug 18, 2016
    Last Update Posted:
    May 6, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Simvastatin
    Pravastatin

    Study Results

    No Results Posted as of May 6, 2021