Chagas CardiomyopathyPhase 3NCT00349271
Cell Therapy in Chagas Cardiomyopathy
A Phase 3 study testing Stem cell, Filgrastime (G-CSF) and Standart therapy in people with Chagas Cardiomyopathy, run by Ministry of Health, Brazil at 1 site in Brazil.
Trial summary
The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chagas Cardiomyopathy
- What is being tested?
- Stem cell, Filgrastime (G-CSF) and Standart therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Dec 2011
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dilated cardiomyopathy according to WHO criteria
- Syndromic heart failure in functional class III or IV of the NYHA
- Enrollment and continuous follow-up in cardiac out-patient clinic
- Adequate medical therapy after optimization therapy
- Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule
Who cannot join
- Valvular diseases, except functional mitral or tricuspid reflow
- Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
- Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
- Sustained ventricular tachycardia
- Abusive use of alcohol or illicit drugs
- Pregnancy
Show all 12Show fewer
- Use of cardio toxic drugs
- Any co-morbidity with impact in life expectancy in 2 years
- Renal function compromised (creatinine above 2 mg/dl)
- Definitive implant of pace-makers, resynchronizers and CDIs
- Heart failure with symptoms initiating less than 1 year ago
- Active systemic arterial hypertension or history of hypertension
Trial locations and contacts
1 site in 1 country.
Brazil1 site
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Rio de Janeiro, 22.240-006
About this study
Official title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy
The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy
Read the detailed description
This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.
The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.
- Conditions
- Chagas Cardiomyopathy
- Being tested
- Stem cell, Filgrastime (G-CSF), Standart therapy
- Keywords
- Chagas Cardiomyopathy, Dilated Cardiomyopathy, stem cells, Therapeutics, Randomized Controlled Trials
- Medical subject headings
- Chagas Cardiomyopathy, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cellProcedure or surgery
Stem cell
Filgrastime (G-CSF)Drug
Filgrastime (G-CSF)
Standart therapyDrug
All drug with clinical evidence of benefical effect in Chagas disease
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell therapy | Experimental | Stem Cell therapy Receives: Procedure: Stem cell; Drug: Filgrastime (G-CSF) |
| Standart therapy | Active comparator | Standart therapy Receives: Drug: Standart therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase of the ejection fraction of the left ventricle
Measured: 1 year
Secondary outcomes (4)
Death by any cause within 1 year of intervention
Measured: 1 year
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline
Measured: 1 year
Difference in NYHA functional class at six months and baseline
Measured: six months
Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2010
- Study completionDec 2011
Why it stopped: Change the sample size due to smaller variance than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chagas CardiomyopathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Brazil
- Sponsor type
- Other government
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Principal investigator, Bernardo Rangel Tura, Ministry of Health, Brazil
- Investigators
- Ricardo R Santos, MD,PhD, Principal investigator, Centro de pesquisa Gonzalo MunizGilson Feitosa, MD, Principal investigator, Hospital Santa Isabel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349271
- Sponsor's protocol ID
- EMRTCC-CHG
- Status last verified
- Mar 2017
- First submitted
- 5 Jul 2006
- Last updated
- 13 Mar 2017
- Results posted
- No
Publications
Ribeiro Dos Santos R, Rassi S, Feitosa G, Grecco OT, Rassi A Jr, da Cunha AB, de Carvalho VB, Guarita-Souza LC, de Oliveira W Jr, Tura BR, Soares MB, Campos de Carvalho AC; Chagas Arm of the MiHeart Study Investigators. Cell therapy in Chagas cardiomyopathy (Chagas arm of the multicenter randomized trial of cell therapy in cardiopathies study): a multicenter randomized trial. Circulation. 2012 May 22;125(20):2454-61. doi: 10.1161/CIRCULATIONAHA.111.067785. Epub 2012 Apr 20.
PubMed 22523306
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00349271
- Acronym / sponsor ID
- EMRTCC-CHG
- Conditions
- Chagas Cardiomyopathy
- Keywords
- Chagas Cardiomyopathy, Dilated Cardiomyopathy, stem cells, Therapeutics, Randomized Controlled Trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change the sample size due to smaller variance than expected
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Ministry of Health, BrazilOther government
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- Jan 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Jul 2006 (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.
The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy
Detailed description
This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.
The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem Cell therapy | Experimental | Procedure: Stem cell, Drug: Filgrastime (G-CSF)Stem Cell therapy |
| Standart therapy | Active comparator | Drug: Standart therapyStandart therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of dilated cardiomyopathy according to WHO criteria
- Syndromic heart failure in functional class III or IV of the NYHA
- Enrollment and continuous follow-up in cardiac out-patient clinic
- Adequate medical therapy after optimization therapy
- Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule
Key exclusion criteria (12 listed)
- Valvular diseases, except functional mitral or tricuspid reflow
- Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
- Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
- Sustained ventricular tachycardia
- Abusive use of alcohol or illicit drugs
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 |
|---|---|---|
| Stem cellStem cell | Procedure or surgery | Stem Cell therapy |
| Filgrastime (G-CSF)Filgrastime (G-CSF) | Drug | Stem Cell therapy |
| Standart therapyAll drug with clinical evidence of benefical effect in Chagas disease | Drug | Standart therapy |
Primary outcome
increase of the ejection fraction of the left ventricle
Time frame: 1 year
4 secondary outcomes
Death by any cause within 1 year of intervention
Time frame: 1 year
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline
Time frame: 1 year
Difference in NYHA functional class at six months and baseline
Time frame: six months
Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Change the sample size due to smaller variance than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Derived from this study: PubMed 22523306Ribeiro Dos Santos R, Rassi S, Feitosa G, Grecco OT, Rassi A Jr, da Cunha AB, de Carvalho VB, Guarita-Souza LC, de Oliveira W Jr, Tura BR, Soares MB, Campos de Carvalho AC; Chagas Arm of the MiHeart Study Investigators. Cell therapy in Chagas cardiomyopathy (Chagas arm of the multicenter randomized trial of cell therapy in cardiopathies study): a multicenter randomized trial. Circulation. 2012 May 22;125(20):2454-61. doi: 10.1161/CIRCULATIONAHA.111.067785. Epub 2012 Apr 20.
Related trials for Chagas Cardiomyopathy
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, 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.
Ricardo R Santos, MD,PhD principal investigator
Centro de pesquisa Gonzalo Muniz
Gilson Feitosa, MD principal investigator
Hospital Santa Isabel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stem cell, Filgrastime (G-CSF) and Standart therapy in people with Chagas Cardiomyopathy, run by Ministry of Health, Brazil at 1 site in Brazil.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 13 Mar 2017. 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 Brazil. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change the sample size due to smaller variance than expected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase of the ejection fraction of the left ventricle (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00349271, which also lists 1 linked publication.
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 13 Mar 2017.