Cell Therapy in Chagas Cardiomyopathy

NCT ID: NCT00349271

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Chagas Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stem Cell therapy

Stem Cell therapy

Group Type: EXPERIMENTAL

Stem cell

Intervention Type: PROCEDURE

Stem cell

Filgrastime (G-CSF)

Intervention Type: DRUG

Filgrastime (G-CSF)

Standart therapy

Standart therapy

Group Type: ACTIVE_COMPARATOR

Standart therapy

Intervention Type: DRUG

All drug with clinical evidence of benefical effect in Chagas disease

Interventions

Stem cell

Stem cell

Intervention Type: PROCEDURE

Filgrastime (G-CSF)

Filgrastime (G-CSF)

Intervention Type: DRUG

Standart therapy

All drug with clinical evidence of benefical effect in Chagas disease

Intervention Type: DRUG

Eligibility Criteria

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Financiadora de Estudos e Projetos

OTHER

Sponsor Role: collaborator

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Bernardo Rangel Tura

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo R Santos, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Centro de pesquisa Gonzalo Muniz

Gilson Feitosa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Santa Isabel

Locations

INCL - National Institute of Cardiology Laranjeiras

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 22523306 (View on PubMed)

Other Identifiers

EMRTCC-CHG

Identifier Type: -

Identifier Source: org_study_id