THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure

NCT01640639 | Unknown Phase 4 DMC

• 1 other identifier: 430/2012/D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

left ventricular function

Outcome Measures

Primary Outcomes (1)

• Changes in left ventricular ejection fraction

  changes in left ventricular ejection fraction at 6 months as compared with baseline

  baseline and 6 months

Secondary Outcomes (1)

• Changes in NYHA functional class

  baseline and 6 months

Study Arms (2)

Thalidomide

ACTIVE COMPARATOR

Thalidomide

Drug: Thalidomide

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Thalidomide DRUG

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

Thalidomide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular ejection fraction \< 50%
• Signs and symptoms of stable CHF
• NYHA III or IV functional class

You may not qualify if:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
• Clinical instability

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

University La Sapienza

Rome, 00166, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+39064997; f.pelliccia@mclink.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 16, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

IT (1)