N/A
N=29
Proteolytic Enzyme Induction Within the Human Myocardial Interstitium
Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00744211 ↗Enrolled (actual)
29
Serious AEs
62.1%
Results posted
Nov 2017
Primary outcome: Primary: Pulmonary Vascular Resistance — 153.8; 213.0; 174.6; 123.5 dyne*second/centimeter˄5 — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1mg/kg sitaxsentan sodium (Drug); 2mg/kg sitaxsentan sodium (Drug); Vehicle (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Vascular Resistance |
153.8; 213.0; 174.6; 123.5; 125.3; 175.8 | <0.05 sig |
| SECONDARY Plasma Endothelin-1 |
3.9; 3.7; 4.3; 5.5; 4.7; 4.1 | 0.001 sig |
Summary
A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (CPB). Increased ET-AR activation has been identified in patients with poor left ventricular (LV) function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF.
Eligibility Criteria
Inclusion Criteria
- >60 years of age
- Body mass index 1.5 times the upper limit of normal
- Patient is pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00744211). 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.