Cell Therapy in Chagas Cardiomyopathy

Chagas Cardiomyopathy Clinical Trial

Official title:

Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00349271
• Other study ID #: EMRTCC-CHG
• Status: Terminated
• Phase: Phase 3
• First received: July 5, 2006
• Last updated: March 9, 2017
• Start date: January 2006
• Est. completion date: December 2011

Study information

• Verified date: March 2017
• Source: Ministry of Health, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 182
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Chagas Cardiomyopathy

Intervention

Procedure:
• Stem cell
Stem cell

Drug:
• Filgrastime (G-CSF)
Filgrastime (G-CSF)
• Standart therapy
All drug with clinical evidence of benefical effect in Chagas disease

Locations

Country	Name	City	State
Brazil	INCL - National Institute of Cardiology Laranjeiras	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Brazil	Financiadora de Estudos e Projetos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase of the ejection fraction of the left ventricle		1 year
Secondary	Death by any cause within 1 year of intervention		1 year
Secondary	Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline		1 year
Secondary	Difference in NYHA functional class at six months and baseline		six months
Secondary	Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months		1 year