Status:
COMPLETED
Spironolactone in Patients With Single Ventricle Heart
Lead Sponsor:
Emory University
Conditions:
Congenital Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions. Usin...
Detailed Description
Spironolactone The starting dose of spironolactone is 1 mg/kg/day. After two weeks this dose will be doubled to the same maximum dose (2/mg/kg/day) as in RALES. If side effects occur or plasma urea an...
Eligibility Criteria
Inclusion
- Single Ventricle Subjects
- \>17 years
- have undergone Fontan Procedure
Exclusion
- History of smoking
- Diabetes mellitus
- Renal failure (serum creatinine \> 2.5 mg/dl)
- Recovering spironolactone for maintenance therapy
- History of hyperkalemia (serum potassium\> 5.5 mEq/L)
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00211081
Start Date
November 1 2004
End Date
June 1 2008
Last Update
November 6 2017
Active Locations (1)
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1
Emory Clinic
Atlanta, Georgia, United States, 30322