THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01640639

Acronym

THUNDER

Enrollment

100

Registered

2012-07-16

Start date

2012-07-31

Completion date

2014-12-31

Last updated

2013-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

left ventricular function

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

Interventions

DRUGThalidomide

Thalidomide, pill, 50 mg, once p.d., 6 weeks

DRUGPlacebo

Placebo, pill, once p.d., 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in left ventricular ejection fraction	baseline and 6 months	changes in left ventricular ejection fraction at 6 months as compared with baseline

Secondary

Measure	Time frame	Description
Changes in NYHA functional class	baseline and 6 months	changes in NYHA functional class at 6 months as compared with baseline

Countries

Italy

Contacts

Primary ContactFrancesco Pelliccia, MD

f.pelliccia@mclink.it+39064997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026