NCT02871648

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

3.8 years

First QC Date

August 15, 2016

Last Update Submit

June 4, 2021

Conditions

Healthy Volunteers

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • Serum aldosterone after angiotensin II infusion

    Aldosterone levels after 30 mins AngII infusion

    5 days

Secondary Outcomes (3)

  • Serum aldosterone after cosyntropin infusion

    5 days

  • Serum cortisol after angiotensin II infusion

    5 days

  • Serum cortisol after cosyntropin infusion

    5 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Fludrocortisone

ACTIVE COMPARATOR

Subjects will receive 0.1 mg of fludrocortisone (Florinef) on one of three study days.

Drug: Fludrocortisone

Epleronone

ACTIVE COMPARATOR

Subjects will receive 100 mg of epleronone on one of three study days.

Drug: Eplerenone

Interventions

PlaceboDRUG

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

Placebo
FludrocortisoneDRUG

Fludrocortisone 0.1 mg

Also known as: Florinef
Fludrocortisone
EplerenoneDRUG

Epleronone 100 mg

Also known as: Inspra
Epleronone

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Braley LM, Williams GH. Rat adrenal cell sensitivity to angiotensin II, alpha-1-24-ACTH, and potassium: a comparative study. Am J Physiol. 1977 Nov;233(5):E402-6. doi: 10.1152/ajpendo.1977.233.5.E402.

    PMID: 200147BACKGROUND

MeSH Terms

Interventions

Fludrocortisonefludrocortisone acetateEplerenone

Intervention Hierarchy (Ancestors)

HydrocortisonePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsLactonesOrganic Chemicals

Study Officials

  • Jonathan S Williams, MD, MMSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 18, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)