Cell Therapy in Chagas Cardiomyopathy

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

Study Overview

• Status: Terminated
• Conditions: Chagas Cardiomyopathy
• Intervention / Treatment: Procedure: Stem cell; Drug: Filgrastime (G-CSF); Drug: Standart therapy

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 Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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)
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stem Cell therapy	Procedure: Stem cell; Stem cell; Drug: Filgrastime (G-CSF); Filgrastime (G-CSF)
Active Comparator: Standart therapy	Drug: Standart therapy; All drug with clinical evidence of benefical effect in Chagas disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
increase of the ejection fraction of the left ventricle	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Death by any cause within 1 year of intervention	1 year
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline	1 year
Difference in NYHA functional class at six months and baseline	six months
Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months	1 year

Collaborators and Investigators

• Sponsor: Ministry of Health, Brazil
• Collaborators: Financiadora de Estudos e Projetos
• Investigators: Principal Investigator: Ricardo R Santos, MD,PhD, Centro de pesquisa Gonzalo Muniz; Principal Investigator: Gilson Feitosa, MD, Hospital Santa Isabel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 5, 2006
• First Submitted That Met QC Criteria: July 5, 2006
• First Posted (Estimate): July 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: Chagas Cardiomyopathy; Dilated Cardiomyopathy; stem cells; Therapeutics; Randomized Controlled Trials
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Chagas Disease; Trypanosomiasis; Euglenozoa Infections; Cardiomyopathies; Chagas Cardiomyopathy
• Other Study ID Numbers: EMRTCC-CHG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No