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


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Enalapril and Felodipine

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

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
University of Texas
Information provided by: Office of Rare Diseases (ORD)

Purpose

OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.

Condition Treatment or Intervention Phase
Pseudohypoaldosteronism
 Drug: enalapril
 Drug: polystyrene sulfonate
Phase II

MedlinePlus related topics:  Genetic Disorders;   Kidney Diseases;   Metabolic Disorders

Study Type: Interventional
Study Design: Treatment

Further Study Details: 

Expected Total Enrollment:  1

Study start: December 1992

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.

Eligibility

Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA: Pseudohypoaldosteronism

Location Information

Study chairs or principal investigators

Bruce S. Keenan,  Study Chair,  University of Texas   

More Information

Study ID Numbers:  199/11883; UTMB-403
Record last reviewed:  May 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004328
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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