| Registry | NCT02871648 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: double, other |
| Enrollment | 23 (Actual) |
| Sponsor | Brigham and Women's Hospital (Other) |
| Conditions | Healthy Volunteers |
| Interventions | Placebo, Fludrocortisone, Eplerenone (Drug) |
| Dates | start 2016-01-01, primary completion 2019-10-01, completion 2019-12-01, first posted 2016-08-18, last updated 2021-06-08 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials of Placebo All trials of Fludrocortisone
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo | Placebo prepared by Investigational Drug Services at Brigham and Women's Hospital |
| Fludrocortisone | Active comparator | Drug: Fludrocortisone | Subjects will receive 0.1 mg of fludrocortisone (Florinef) on one of three study days. |
| Epleronone | Active comparator | Drug: Eplerenone | Subjects will receive 100 mg of epleronone on one of three study days. |
Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Brigham and Women's Hospital | Boston, Massachusetts | United States |