A Randomized Trial of Carvedilol in Chronic Chagas Cardiomyopathy

NCT01557140 | Completed Phase 4

• 1 other identifier: Carvedilol in Chagas disease
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Chagas cardiomyopathy causes substantial morbidity and mortality in Latin America. Whether RAS inhibitors and beta-blockers are safe and beneficial has been challenged because of the lack of formal trials. Hence, the objective of this study was to determine the safety and efficacy of renin-angiotensin system (RAS) inhibitors and beta-blockers in chronic Chagas cardiomyopathy. This way, the investigators conducted a double-blind, placebo-controlled, and randomized trial in 42 patients with Trypanosoma cruzi infection and cardiomyopathy. All patients received enalapril (up-titrated to 20 mg BID) and spironolactone (25 mg QD). Subsequently, the patients were randomly assigned to receive placebo (n = 20) or carvedilol up-titrated to 25 mg BID (n = 19). The primary end points were change in left ventricular ejection fraction (LVEF) after RAS inhibition and that after the addition of carvedilol. The secondary end points were changes in other echocardiographic parameters, Framingham score, quality of life (36-item Short-Form Health Survey), New York Heart Association class, radiographic indices, brain natriuretic peptide levels, and chemokines as well as safety end points.

Conditions

Chagas Cardiomyopathy; Heart Failure; Dilated Cardiomyopathy

Keywords

Chagas cardiomyopathy,; Renin-angiotensin system,; Beta-blockers,; Enalapril,; Carvedilol,; Renin-angiotensin system inhibitors,; Brain natriuretic peptide level,; Left ventricular ejection fraction,; Chemokines

Outcome Measures

Primary Outcomes (1)

• Changes in left ventricular ejection fraction

  Baseline, 4 months and 8 months

Secondary Outcomes (8)

• Changes in Framingham score

  Baseline, 4 months and 8 months

• Changes in quality of life (36-item Short-Form Health Survey)

  Baseline, 4 months and 8 months

• Changes in New York Heart Association functional class

  Baseline, 4 months and 8 months

• Changes in cardiothoracic ratio

  Baseline, 4 months and 8 months

• Changes in echocardiographic diastolic function indices

  Baseline, 4 months and 8 months

Study Arms (2)

RASi plus placebo

PLACEBO COMPARATOR

RAS inhibition was optimized and after patients were randomly assigned to receive placebo

RASi plus carvedilol

EXPERIMENTAL

RAS inhibition was optimized and after patients were randomly assigned to receive carvedilol

Drug: RASi plus carvedilol

Interventions

RASi plus carvedilol DRUG

Patients were randomly assigned to 2 groups, with 1 group receiving renin-angiotensin system inhibitors (enalapril) plus carvedilol and the other receiving renin-angiotensin system inhibitors (enalapril) plus placebo

Also known as: Randomized, Double blind, Controlled, Trial

RASi plus carvedilol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiomyopathy was present when at least 3 of the following criteria were fulfilled:
• LV enddiastolic diameter (LVDD) N55 mm
• LVDD/body surface area \> 2.7cm/m2
• LV ejection fraction (LVEF) \< 55%
• QRS interval \> 120 ms
• echocardiographic evidence of diffuse or segmental systolic wall motion abnormalities.

You may not qualify if:

• Using any h-blocker
• Having additional comorbidities (eg, hypertension, diabetes mellitus, thyroid dysfunction, chronic obstructive pulmonary disease, asthma, and renal or hepatic failure).

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Chagas Disease Outpatient Center of the Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (1)

• Botoni FA, Poole-Wilson PA, Ribeiro AL, Okonko DO, Oliveira BM, Pinto AS, Teixeira MM, Teixeira AL Jr, Reis AM, Dantas JB, Ferreira CS, Tavares WC Jr, Rocha MO. A randomized trial of carvedilol after renin-angiotensin system inhibition in chronic Chagas cardiomyopathy. Am Heart J. 2007 Apr;153(4):544.e1-8. doi: 10.1016/j.ahj.2006.12.017.

  PMID: 17383291 RESULT

MeSH Terms

Conditions

Chagas Cardiomyopathy; Heart Failure; Cardiomyopathy, Dilated

Interventions

Carvedilol; Random Allocation; Double-Blind Method; Control Groups; Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Chagas Disease; Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Studies as Topic; Epidemiologic Study Characteristics

Study Officials

• Fernando A Botoni, MD, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-General, Hospital das Clínicas, UFMG

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 19, 2012
• Study Start: May 1, 2003
• Primary Completion: March 1, 2004
• Study Completion: December 1, 2006
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

BR (1)