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

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ClinicalTrials.gov Identifier: NCT01640639
Recruitment Status : Unknown
Verified March 2013 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was:  Recruiting
First Posted : July 16, 2012
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Thalidomide Drug: Placebo Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Thalidomide on Left Ventricular Morphology and Function in Patients With Congestive Heart Failure - The THUNDER Trial
Study Start Date : July 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Thalidomide

Arm Intervention/treatment
Active Comparator: Thalidomide
Thalidomide
Drug: Thalidomide
Thalidomide, pill, 50 mg, once p.d., 6 weeks

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo, pill, once p.d., 6 weeks




Primary Outcome Measures :
  1. Changes in left ventricular ejection fraction [ Time Frame: baseline and 6 months ]
    changes in left ventricular ejection fraction at 6 months as compared with baseline


Secondary Outcome Measures :
  1. Changes in NYHA functional class [ Time Frame: baseline and 6 months ]
    changes in NYHA functional class at 6 months as compared with baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640639


Contacts
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Contact: Francesco Pelliccia, MD +39064997 ext 123 f.pelliccia@mclink.it

Locations
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Italy
University La Sapienza Recruiting
Rome, Italy, 00166
Contact: Francesco Pelliccia, MD         
Principal Investigator: Francesco Pelliccia, MD, PhD         
Sponsors and Collaborators
University of Roma La Sapienza

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Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01640639     History of Changes
Other Study ID Numbers: 430/2012/D
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Francesco Pelliccia, University of Roma La Sapienza:
left ventricular function

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents