Overview

THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure

Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
Several studies have shown that inflammation and matrix degradation have pathogenic effects on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling process. The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of congestive heart failure (CHF). Previous, small investigations have shown an improvement in left ventricular ejection fraction and a favorable cardiac remodeling during thalidomide therapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Roma La Sapienza
Treatments:
Thalidomide
Criteria
Inclusion Criteria:

- Left ventricular ejection fraction < 50%

- Signs and symptoms of stable CHF

- NYHA III or IV functional class

Exclusion Criteria:

- Women of child bearing potential patients must demonstrate a negative pregnancy test
performed within 24 hours before CT

- Clinical instability