Congestive Heart FailurePhase 4THUNDERNCT01640639
THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure
A Phase 4 study testing Thalidomide in people with Congestive Heart Failure, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Thalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular ejection fraction < 50%
- Signs and symptoms of stable CHF
- NYHA III or IV functional class
Who cannot join
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
- Clinical instability
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University La Sapienza
Rome, 00166
Francesco Pelliccia, MD
Francesco Pelliccia, MD, PhD
About this study
Official title: Effects of Thalidomide on Left Ventricular Morphology and Function in Patients With Congestive Heart Failure - The THUNDER Trial
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.
Read the 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
- Conditions
- Congestive Heart Failure
- Being tested
- Thalidomide, Placebo
- Keywords
- left ventricular function
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Thalidomide, pill, 50 mg, once p.d., 6 weeks
PlaceboDrug
Placebo, pill, once p.d., 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide | Active comparator | Thalidomide Receives: Drug: Thalidomide |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left ventricular ejection fraction
changes in left ventricular ejection fraction at 6 months as compared with baseline
Measured: baseline and 6 months
Secondary outcomes (1)
Changes in NYHA functional class
changes in NYHA functional class at 6 months as compared with baseline
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640639
- Sponsor's protocol ID
- 430/2012/D
- Acronym
- THUNDER
- Status last verified
- Mar 2013
- First submitted
- 6 Jul 2012
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thalidomide on Left Ventricular Morphology and Function in Patients With Congestive Heart Failure - The THUNDER Trial
- ClinicalTrials.gov ID
- NCT01640639
- Acronym / sponsor ID
- THUNDER / 430/2012/D
- Conditions
- Congestive Heart Failure
- Keywords
- left ventricular function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalidomide | Active comparator | Drug: ThalidomideThalidomide |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Left ventricular ejection fraction < 50%
- Signs and symptoms of stable CHF
- NYHA III or IV functional class
Key exclusion criteria (2 listed)
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
- Clinical instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThalidomideThalidomide, pill, 50 mg, once p.d., 6 weeks | Drug | Thalidomide |
| PlaceboPlacebo, pill, once p.d., 6 weeks | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Changes in NYHA functional class
Time frame: baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
Related trials for Congestive Heart Failure
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thalidomide in people with Congestive Heart Failure, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pelliccia, MD (+39064997 ext. 123, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in left ventricular ejection fraction (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2013.