Back to resultsTHalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure (THUNDER)
Primary Purpose
Congestive Heart Failure
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Thalidomide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring left ventricular function
Eligibility 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
Sites / Locations
- University La SapienzaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Thalidomide
Placebo
Arm Description
Thalidomide
Placebo
Outcomes
Primary Outcome Measures
Changes in left ventricular ejection fraction
changes in left ventricular ejection fraction at 6 months as compared with baseline
Secondary Outcome Measures
Changes in NYHA functional class
changes in NYHA functional class at 6 months as compared with baseline
Full Information
NCT ID
NCT01640639
First Posted
July 6, 2012
Last Updated
March 6, 2013
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01640639
Brief Title
THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure
Acronym
THUNDER
Official Title
Effects of Thalidomide on Left Ventricular Morphology and Function in Patients With Congestive Heart Failure - The THUNDER Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
left ventricular function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thalidomide
Arm Type
Active Comparator
Arm Description
Thalidomide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Thalidomide, pill, 50 mg, once p.d., 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, pill, once p.d., 6 weeks
Primary Outcome Measure Information:
Title
Changes in left ventricular ejection fraction
Description
changes in left ventricular ejection fraction at 6 months as compared with baseline
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Changes in NYHA functional class
Description
changes in NYHA functional class at 6 months as compared with baseline
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Pelliccia, MD
Phone
+39064997
Ext
123
Email
f.pelliccia@mclink.it
Facility Information:
Facility Name
University La Sapienza
City
Rome
ZIP/Postal Code
00166
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Pelliccia, MD
First Name & Middle Initial & Last Name & Degree
Francesco Pelliccia, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure
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