Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I

• Sponsor: National Center for Research Resources (NCRR) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00004328
• Collaborator: University of Texas (Other)
• Enrollment: 1

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism.

1. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance.

2. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.

Condition or Disease	Intervention/Treatment	Phase
Pseudohypoaldosteronism	Drug: enalapril; Drug: polystyrene sulfonate	Phase 2

Detailed Description

PROTOCOL OUTLINE: Sodium and potassium intake resulting in normalization of serum electrolytes and markers of extracellular volume are determined at baseline. A trial diet is then prescribed, with adjustments made to achieve a steady state with normal serum electrolytes. Exercise tolerance and muscle function are evaluated at steady state.

Sodium and potassium are sequentially manipulated with diet, enalapril, and polystyrene sulfonate. Exercise tolerance is evaluated during each diet period.

A treatment plan to maintain electrolyte balance is developed. The patient is followed monthly for 3 to 6 months, then every 3 months for up to 3 years.

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 1992

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

PROTOCOL ENTRY CRITERIA:

Pseudohypoaldosteronism

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Center for Research Resources (NCRR)
• University of Texas

Investigators

• Study Chair: Bruce S. Keenan, University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00004328
• Other Study ID Numbers: 199/11883; UTMB-403
• First Posted: Oct 19, 1999
• Last Update Posted: Jun 24, 2005
• Last Verified: May 1, 2000

• Keywords provided by , ,: endocrine disorders; pseudohypoaldosteronism; rare disease
• Additional relevant MeSH terms: Pseudohypoaldosteronism; Enalapril; Polystyrene sulfonic acid

Study Results

No Results Posted as of Jun 24, 2005