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

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Texas
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004328

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	Intervention	Phase
Pseudohypoaldosteronism	Drug: enalapril Drug: polystyrene sulfonate	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

Drug Information available for: Polystyrene sulfonic acid Calcium polystyrene sulfonate Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	1
Study Start Date:	December 1992

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

Pseudohypoaldosteronism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004328

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Texas

Investigators

Study Chair:

Bruce S. Keenan

University of Texas

More Information

No publications provided

Study ID Numbers:	199/11883, UTMB-403
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004328 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

endocrine disorders
pseudohypoaldosteronism
rare disease

Study placed in the following topic categories:

Adrenal Insufficiency
Metabolic Diseases
Adrenal Gland Hypofunction
Pseudohypoaldosteronism
Rare Diseases
Endocrine System Diseases
Adrenal Gland Diseases
Cardiovascular Agents
Antihypertensive Agents
Hypoadrenalism

Protease Inhibitors
Metabolism, Inborn Errors
Enalapril
Enalaprilat
Urologic Diseases
Genetic Diseases, Inborn
Angiotensin-Converting Enzyme Inhibitors
Kidney Diseases
Endocrinopathy
Metabolic Disorder

Additional relevant MeSH terms:

Adrenal Insufficiency
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Pseudohypoaldosteronism
Adrenal Gland Diseases
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Renal Tubular Transport, Inborn Errors
Antihypertensive Agents

Pharmacologic Actions
Protease Inhibitors
Metabolism, Inborn Errors
Enalapril
Urologic Diseases
Genetic Diseases, Inborn
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Kidney Diseases

ClinicalTrials.gov processed this record on September 03, 2009