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Dilated CardiomyopathyPhase 3NCT00333827

Cell Therapy In Dilated Cardiomyopathy

A Phase 3 study testing optimal therapy for cardiaca failure and cell in people with Dilated Cardiomyopathy, run by Ministry of Health, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Dilated Cardiomyopathy
What is being tested?
optimal therapy for cardiaca failure and cell
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteBrazil
Study dates
Jan 2006to Feb 2013
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 9Show 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)

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

Other trials in Brazil

About this study

Official title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated 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.

Hypothesis: The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.

Being tested
optimal therapy for cardiaca failure, cell
Keywords
Dilated Cardiomyopathy, stem cells, Therapeutics, Randomized Controlled Trials
Medical subject headings
Cardiomyopathy, Dilated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • optimal therapy for cardiaca failureDrug

    optimal therapy for cardiaca failure

  • cellProcedure or surgery

    stem cell

Study groups in NCT00333827
Study groupRoleWhat they receive
Optimal TherapyActive comparatorOptimal therapy for cardiac failure
Receives: Drug: optimal therapy for cardiaca failure
cell therapyExperimentalstem cell
Receives: Procedure: cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. increase of the ejection fraction of the left ventricle

    Measured: 6 months

Secondary outcomes (5)

  1. Death by any cause

    Measured: 1 year

  2. Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline

    Measured: 1 year

  3. Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire

    Measured: 6 month

  4. Difference in NYHA functional class

    Measured: 6 month

  5. Percent number of patients that reached an absolute increase of 5% in ejection fraction

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionDec 2012
  4. Study completionFeb 2013

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00333827
Sponsor's protocol ID
EMRTCC-MCD
Status last verified
Mar 2017
First submitted
5 Jun 2006
Last updated
13 Mar 2017
Results posted
No

Publications

  • Martino H, Brofman P, Greco O, Bueno R, Bodanese L, Clausell N, Maldonado JA, Mill J, Braile D, Moraes J Jr, Silva S, Bozza A, Santos B, Campos de Carvalho A; Dilated Cardiomyopathy Arm of the MiHeart Study Investigators. Multicentre, randomized, double-blind trial of intracoronary autologous mononuclear bone marrow cell injection in non-ischaemic dilated cardiomyopathy (the dilated cardiomyopathy arm of the MiHeart study). Eur Heart J. 2015 Nov 7;36(42):2898-904. doi: 10.1093/eurheartj/ehv477. Epub 2015 Sep 20.

    PubMed 26392433

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing optimal therapy for cardiaca failure and cell in people with Dilated 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 9 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 6 months). 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 NCT00333827, 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.

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