THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure — THUNDER  

Congestive Heart Failure Clinical Trial

Official title: Effects of Thalidomide on Left Ventricular Morphology and Function in Patients With Congestive Heart Failure - The THUNDER Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

• NCT number: NCT01640639
• Study type: Interventional
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD
• Phone: +39064997
• Email: f.pelliccia@mclink.it
• Status: Recruiting
• Phase: Phase 4
• Start date: July 2012
• Completion date: December 2014