At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Diagnosis of single ventricle heart
- ✓Prior Fontan procedure
- ✕History of smoking
- ✕Diabetes mellitus
- ✕Renal failure with serum creatinine >2.5 mg/dL
- ✕Already receiving spironolactone for maintenance therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Impact of Spironolactone on Endothelial Function in Patients With Single Ventricle Heart
In Brief
A clinical study evaluating Spironolactone (drug) for Congenital Disorders. Completed, enrolled 12 participants across 1 site.
Detailed 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. Using ultrasound we can see how arteries change with movement or even drugs. We want to use ultrasound to see how blood vessels look in patients with Congestive Heart Failure (CHF) and to also see how a drug called Spironolactone, commonly prescribed for patients with this disease, effects blood vessel function in patients with congestive heart failure. This information may be used to change the standard of care for patients with heart failure especially if we show that Spironolactone has a positive effect on vessel function in patients with CHF.
Study Details
Timeline
Interventions
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.