Cell Therapy In Dilated Cardiomyopathy

March 9, 2017 updated by: Bernardo Rangel Tura, Ministry of Health, Brazil

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22.240-006
        • INCL - National Institute of Cardiology Laranjeiras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Use of cardio toxic drugs
  • Any co-morbidity with impact in life expectancy in 2 years
  • Renal function compromised (creatinine above 2 mg/dl)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Optimal Therapy
Optimal therapy for cardiac failure
Drug: optimal therapy for cardiaca failure
optimal therapy for cardiaca failure
Experimental: cell therapy
stem cell
Procedure: cell
stem cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
increase of the ejection fraction of the left ventricle
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Death by any cause
Time Frame: 1 year
1 year
Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline
Time Frame: 1 year
1 year
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire
Time Frame: 6 month
6 month
Difference in NYHA functional class
Time Frame: 6 month
6 month
Percent number of patients that reached an absolute increase of 5% in ejection fraction
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Brazil

Collaborators

Financiadora de Estudos e Projetos

Investigators

  • Study Director: Antonio Carlos C de Carvalho, MD,PhD, INCL
  • Study Chair: Bernardo R Tura, Md,MsC, INCL
  • Principal Investigator: Augusto Z Bozza, MD, INCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 5, 2006

First Submitted That Met QC Criteria

June 5, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMRTCC-MCD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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