Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004328
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism Type I
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTMB-403 | None | None | None |