Trial record 2 of 4 for:    "pseudohypoaldosteronism type 1" OR "Pseudohypoaldosteronism"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004328
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
University of Texas
Information provided by:
Office of Rare Diseases (ORD)

Brief 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.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Primary Purpose: Treatment
Study Start Date : December 1992

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No



Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004328

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Texas
Study Chair: Bruce S. Keenan University of Texas Identifier: NCT00004328     History of Changes
Other Study ID Numbers: 199/11883
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2000

Keywords provided by Office of Rare Diseases (ORD):
endocrine disorders
rare disease

Additional relevant MeSH terms:
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Polystyrene sulfonic acid
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Chelating Agents
Sequestering Agents