Trial record 14 of 19 for:
eplerenone | Recruiting, Not yet recruiting, Available Studies
The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production
This study is currently recruiting participants.
Verified July 2017 by Gordon H. Williams, MD, Brigham and Women's Hospital
First Posted: August 18, 2016
Last Update Posted: July 18, 2017
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Information provided by (Responsible Party):
Gordon H. Williams, MD, Brigham and Women's Hospital
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.
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
||The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production
Primary Outcome Measures:
- Serum aldosterone after angiotensin II infusion [ Time Frame: 5 days ]
Secondary Outcome Measures:
- Serum aldosterone after cosyntropin infusion [ Time Frame: 5 days ]
- Serum cortisol after angiotensin II infusion [ Time Frame: 5 days ]
- Serum cortisol after cosyntropin infusion [ Time Frame: 5 days ]
- 24 hour urine aldosterone [ Time Frame: Baseline ]
- 24 hour urine aldosterone [ Time Frame: 5 days ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2018 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
Placebo prepared by Investigational Drug Services at Brigham and Women's Hospital
Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital
Active Comparator: Fludrocortisone
Subjects will receive 0.1 mg of fludrocortisone (Florinef) on one of three study days.
Fludrocortisone 0.1 mg
Other Name: Florinef
Active Comparator: Epleronone
Subjects will receive 100 mg of epleronone on one of three study days.
Epleronone 100 mg
Other Name: Inspra
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).
Information from the National Library of Medicine
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|Ages Eligible for Study:
||18 Years to 40 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871648
|Brigham and Women's Hospital
|Boston, Massachusetts, United States, 02115 |
|Principal Investigator: Jonathan S Williams, MD, MMSc |
|Sub-Investigator: Gordon Williams, MD |
|Sub-Investigator: Tina Gupta, MD |
Brigham and Women's Hospital
||Jonathan S Williams, MD, MMSc
||Brigham and Women's Hospital
||Gordon H. Williams, MD, Principal Investigator, Brigham and Women's Hospital
History of Changes
|Other Study ID Numbers:
||August 15, 2016
||August 18, 2016
|Last Update Posted:
||July 18, 2017
|Individual Participant Data (IPD) Sharing Statement:
|Plan to Share IPD:
Keywords provided by Gordon H. Williams, MD, Brigham and Women's Hospital:
Additional relevant MeSH terms:
Mineralocorticoid Receptor Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing