THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure

Congestive Heart Failure Clinical Trial

— THUNDER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01640639
• Other study ID #: 430/2012/D
• Status: Recruiting
• Phase: Phase 4
• First received: July 6, 2012
• Last updated: March 6, 2013
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2013
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD
• Phone: +39064997
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• Thalidomide
Thalidomide, pill, 50 mg, once p.d., 6 weeks
• Placebo
Placebo, pill, once p.d., 6 weeks

Locations

Country	Name	City	State
Italy	University La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in left ventricular ejection fraction	changes in left ventricular ejection fraction at 6 months as compared with baseline	baseline and 6 months	No
Secondary	Changes in NYHA functional class	changes in NYHA functional class at 6 months as compared with baseline	baseline and 6 months	No