Spironolactone in Patients With Single Ventricle Heart
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|ClinicalTrials.gov Identifier: NCT00211081|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : December 16, 2014
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Congenital Disorders||Drug: Spironolactone (drug)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Spironolactone on Endothelial Function in Patients With Single Ventricle Heart|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
|Experimental: Open Label||
Drug: Spironolactone (drug)
1 mg/kg/day; afer 2 weeks doubled to 2/mg/kg/day. Patient's with endothelium-dependent brachial artery vasodilation and single-ventricle should show improvement within 4-8 weeks. Patients and their labs who are receiving Spironolactone will be followed.
- Change in Flow Mediated Dilation [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.
- C-Reactive Protein Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]The normal reference range for C-reactive protein is as follows: CRP: 0-10mg/L
- Interleukin-6 (IL-6) Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]The normal result for IL-6 for Interleukin 6 is < 5pg/ml.
- Interleukin 1 Beta (IL1b) Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]The normal result for IL1b is <3.9 pg/mL.
- Interleukin-10 (IL10) Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]The normal result for IL-10 for Interleukin 10 is < 18pg/ml.
- Tumor Necrosis Factor-Alpha (TNF-a) Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]The normal result for TNF-a is <5.6 pg/mL.
- Change in 6 Minute Walk Test Score [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]
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 ClinicalTrials.gov identifier (NCT number): NCT00211081
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||William T Mahle, MD||Emory University|
|Principal Investigator:||Arshed Quyyumi, MD||Emory University|
|Principal Investigator:||Wendy M Book, MD||Emory University|
|Principal Investigator:||Michael E McConnell, MD||Emory University|