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Studies on Aldosterone and Vascular Function

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00700479
First received: December 25, 2007
Last updated: June 17, 2008
Last verified: June 2008
History of Changes
  Purpose

A randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects.


Condition Intervention Phase
Inflammation
 Drug: aldosterone
Dietary Supplement: low or high sodium diet
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Studies on Aldosterone and Vascular Function

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Flow mediated dilation brachial artery [ Time Frame: 0 and 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Aldosterone plus low salt diet
 Drug: aldosterone
4 hour infusion
Dietary Supplement: low or high sodium diet
Experimental: B
Aldosterone plus high sodium diet
 Drug: aldosterone
4 hour infusion
Dietary Supplement: low or high sodium diet
Placebo Comparator: C
Placebo plus low sodium diet
 Dietary Supplement: low or high sodium diet Drug: placebo
placebo
Placebo Comparator: D
placebo plus high sodium diet
 Dietary Supplement: low or high sodium diet Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects age >18 years

Exclusion Criteria:

  • Any chronic medical disease or chronic use of medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700479

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Pfizer
Investigators
Principal Investigator: Stuart Katz, MD Yale School of Medicine
  More Information

No publications provided

Responsible Party: Stuart Katz, Yale School of Medicine
ClinicalTrials.gov Identifier: NCT00700479     History of Changes
Other Study ID Numbers: 602001143
Study First Received: December 25, 2007
Last Updated: June 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
vascular endothelium
nitric oxide
aldosterone
vascular biology

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013