Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pseudohypoaldosteronism
Intervention: enalapril (Drug); polystyrene sulfonate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s): Bruce S. Keenan, Study Chair, Affiliation: University of Texas
Summary
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.
Clinical Details
Study design: Primary Purpose: Treatment
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
Pseudohypoaldosteronism
Locations and Contacts
Additional Information
Starting date: December 1992
Last updated: June 23, 2005
|