We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
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
Sponsor:
ClinicalTrials.gov Identifier:
NCT02871648
First Posted: August 18, 2016
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gordon H. Williams, MD, Brigham and Women's Hospital
  Purpose
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.

Condition Intervention Phase
Healthy Volunteers Drug: Placebo Drug: Fludrocortisone Drug: Eplerenone Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production

Resource links provided by NLM:


Further study details as provided by Gordon H. Williams, MD, Brigham and Women's Hospital:

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: 20
Study Start Date: January 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo prepared by Investigational Drug Services at Brigham and Women's Hospital
Drug: Placebo
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.
Drug: Fludrocortisone
Fludrocortisone 0.1 mg
Other Name: Florinef
Active Comparator: Epleronone
Subjects will receive 100 mg of epleronone on one of three study days.
Drug: Eplerenone
Epleronone 100 mg
Other Name: Inspra

Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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


Contacts
Contact: Cara Ludwick 617-278-0305 cludwick1@partners.org
Contact: Jonathan S Williams, MD, MMSc 617-278-0882 jwilliams5@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Jonathan S Williams, MD, MMSc         
Sub-Investigator: Gordon Williams, MD         
Sub-Investigator: Tina Gupta, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jonathan S Williams, MD, MMSc Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Gordon H. Williams, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02871648     History of Changes
Other Study ID Numbers: 2015P001664
First Submitted: August 15, 2016
First Posted: August 18, 2016
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gordon H. Williams, MD, Brigham and Women's Hospital:
Healthy

Additional relevant MeSH terms:
Eplerenone
Fludrocortisone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Anti-Inflammatory Agents