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OpenTrials
Completed

NCT Number: NCT02871687

Effect of Statin Use on Aldosterone Secretion

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brigham and Women's Hospital- 221 Longwood Avenue

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

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

Other names: Zocor

Pravastatin

Drug

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

Other names: Pravachol

Placebo

Other

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

Primary outcomes

  1. Serum aldosterone following angiotensin II infusion

    Time frame: 3 months

Secondary outcomes

  1. 24 hour urine aldosterone

    Time frame: Baseline

  2. 24 hour urine aldosterone

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2016
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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