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

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Congestive Heart Failure

Treatments: Drug: Thalidomide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01640639

430/2012/D

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Thalidomide

Active Comparator group

Description:

Thalidomide

Treatment:

Drug: Thalidomide

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo