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Completed

NCT Number: NCT02871648

The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production

The purpose of this research protocol is to determine if the same effects are observed in vivo in humans using a similar approach. Demonstrating that mineralocorticoid acts on zona glomerulosa cells to regulate aldosterone production in a short feedback loop would provide important insight into hormone regulation, and explain variability in pathophysiologic states such as hypertension and cardiovascular diseases.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

In order to provide additional evidence indicating the presence of functional and in order to provide additional evidence indicating the presence of functional mineralocorticoid receptors (MR) on zona glomerulosa (ZG) cells, the investigators propose the following protocol in healthy volunteers. The investigators will evaluate aldosterone and cortisol production in response to an angiotensin II infusion after three separate test conditions: 1) placebo, 2) following a single dose of fludrocortisone, and 3) following a single dose of eplerenone (a MR antagonist).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be healthy, with no prior history of hypertension, no family history of hypertension, diabetes, stroke or cardiac disease in first-degree relatives before the age of 70 years and have an average (two measurements) blood pressure of <130/89 mm Hg and >100/50 mmHg at the screening visit.
  • All subjects will have body mass index 19-25 kg/m2.
  • Subjects must have normal laboratory values for: Complete blood count; serum creatinine, sodium, potassium, glucose, liver enzymes; urinalysis; negative urine HCG in women; normal ECG

Exclusion criteria

  • Alcohol intake >12oz per week, as well as tobacco or recreational drug use.
  • Any subject with a history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months will be excluded from the study.
  • Subjects taking any prescription medications (with the exception of birth control pills) or herbal medications will be excluded.
  • Because of the unknown risk of infused angiotensin II in pregnancy, women who are pregnant will be excluded from study and all women will be screened for pregnancy by quantitative serum hCG measurement on the day of each CCI admission.
  • Women currently breastfeeding will also be excluded from the study.

Treatment and study plan

Placebo

Drug

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

fludrocortisone

Drug

Fludrocortisone 0.1 mg

Other names: Florinef

Eplerenone

Drug

Epleronone 100 mg

Other names: Inspra

Primary outcomes

  1. Serum aldosterone after angiotensin II infusion

    Time frame: 5 days

    Aldosterone levels after 30 mins AngII infusion

Secondary outcomes

  1. Serum aldosterone after cosyntropin infusion

    Time frame: 5 days

    Aldosterone levels after 30 mins cosyntropin infusion

  2. Serum cortisol after angiotensin II infusion

    Time frame: 5 days

    Cortisol levels after 30 mins AngII infusion

  3. Serum cortisol after cosyntropin infusion

    Time frame: 5 days

    Cortisol levels after 30 mins cosyntropin infusion

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2016
Registry last updated
Jun 8, 2021

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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