THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: Thalidomide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thalidomide<br>Thalidomide | Drug: Thalidomide<br>* Thalidomide, pill, 50 mg, once p.d., 6 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo, pill, once p.d., 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in left ventricular ejection fraction | changes in left ventricular ejection fraction at 6 months as compared with baseline | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in NYHA functional class | changes in NYHA functional class at 6 months as compared with baseline | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left ventricular function