N/A
Completed N=12
Spironolactone in Patients With Single Ventricle Heart
Source: ClinicalTrials.gov NCT00211081 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Change in Flow Mediated Dilation — 5.5 Percentage of brachial artery diameter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Flow Mediated Dilation |
5.5 | — |
| SECONDARY C-Reactive Protein Level |
1.10; 1.10 | — |
| SECONDARY Interleukin-6 (IL-6) Level |
1.96; 1.54 | — |
| SECONDARY Interleukin 1 Beta (IL1b) Level |
.38; .23 | — |
| SECONDARY Interleukin-10 (IL10) Level |
.26; .13 | — |
| SECONDARY Tumor Necrosis Factor-Alpha (TNF-a) Level |
2.20; 2.42 | — |
| SECONDARY Change in 6 Minute Walk Test Score |
— | — |
Eligibility Criteria
Inclusion Criteria
- Single Ventricle Subjects
- >17 years
- have undergone Fontan Procedure
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00211081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.