THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure

Phase 4

• Conditions: Congestive Heart Failure
• Interventions: Drug: Placebo; Drug: Thalidomide

• Registration Number: NCT01640639
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

Detailed Description

Purpose

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.

Purpose

The primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on left ventricular morphology and function in patients with CHF

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-16
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-07
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Thalidomide	Thalidomide	Thalidomide

Primary Outcome Measures

Name	Time	Method
Changes in left ventricular ejection fraction	baseline and 6 months	changes in left ventricular ejection fraction at 6 months as compared with baseline

Secondary Outcome Measures

Name	Time	Method
Changes in NYHA functional class	baseline and 6 months	changes in NYHA functional class at 6 months as compared with baseline

Trial Locations

Locations (1)

University La Sapienza; 🇮🇹 Rome, Italy