A Phase 1 interventional study of Placebo and Fludrocortisone in Healthy Volunteers, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-08.
Sponsored by Brigham and Women's Hospital · Phase 1, Interventional, and Other
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.
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).
Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo prepared by Investigational Drug Services at Brigham and Women's Hospital
Drug: Placebo
Subjects will receive 0.1 mg of fludrocortisone (Florinef) on one of three study days.
Drug: Fludrocortisone
Subjects will receive 100 mg of epleronone on one of three study days.
Drug: Eplerenone
Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital
Fludrocortisone 0.1 mg
Also known as: Florinef
Epleronone 100 mg
Also known as: Inspra
Serum aldosterone after angiotensin II infusion
Aldosterone levels after 30 mins AngII infusion
Time frame: 5 days
Serum aldosterone after cosyntropin infusion
Aldosterone levels after 30 mins cosyntropin infusion
Time frame: 5 days
Serum cortisol after angiotensin II infusion
Cortisol levels after 30 mins AngII infusion
Time frame: 5 days
Serum cortisol after cosyntropin infusion
Cortisol levels after 30 mins cosyntropin infusion
Time frame: 5 days
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital