NCT02871687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

4.9 years

First QC Date

August 15, 2016

Last Update Submit

September 28, 2022

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Serum aldosterone following angiotensin II infusion

    3 months

Secondary Outcomes (2)

  • 24 hour urine aldosterone

    Baseline

  • 24 hour urine aldosterone

    3 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Simvastatin

ACTIVE COMPARATOR

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

Pravastatin

ACTIVE COMPARATOR

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

Interventions

SimvastatinDRUG

Simvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure

Also known as: Zocor
Simvastatin
PravastatinDRUG

Pravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure

Also known as: Pravachol
Pravastatin
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital- 221 Longwood Avenue

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    PMID: 26432671BACKGROUND

  • 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.

    PMID: 32664962DERIVED

MeSH Terms

Interventions

SimvastatinPravastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Jonathan Williams, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 18, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)