Colchicine for Patients With Chagas´ Disease( B1 Stage)

NCT03704181 | Unknown Phase 2

• 1 other identifier: 4436/16/102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease. Forty patients will receive colchicine while twenty patients will receive placebo

Conditions

Chagas Disease; Colchicine Resistance

Keywords

fibrosis; Inflammation

Outcome Measures

Primary Outcomes (2)

• Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging

  myocardial edema quantified in grams or percent of LV mass, myocardial hyperaemia quantified in grams or percent of LV mass

  1 year

• Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging

  myocardial fibrosis quantified in grams or percent of LV mass

  1 year

Secondary Outcomes (4)

• Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10

  1 year

• Effect of colchicine on inflammatory marker such as TNF-α

  1 year

• Effect of colchicine on inflammatory marker such as interferon-gama

  1 year

• Effect of colchicine on T Cruzi polymerase chain reaction

  1 year

Study Arms (2)

colchicine

EXPERIMENTAL

colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year

Drug: Colchicine 0.5 MG twice day for one year

placebo

ACTIVE COMPARATOR

placebo tablet by mouth every 12 hours, for 1 year pill manufactured to mimic coclchicine 0,5 mg tablet

Drug: Placebo Oral Tablet

Interventions

Colchicine 0.5 MG twice day for one year DRUG

placebo twice day for one year

Also known as: placebo oral tablet

colchicine

Placebo Oral Tablet DRUG

placebo twice day for one year

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and serological diagnosis of Chagas´disease ( Stage B1)
• Must be able to swallow tablets

You may not qualify if:

• myocardial infarction or coronary artery disease,
• diabetes mellitus,
• valvular disease,
• creatinine clearance \<30 ml / kg / min
• contraindication to perform cardiac magnetic resonance imaging
• use of angiotensin converting enzyme inhibitors, angiotensin II receptor blockers and aldosterone blockers
• previous use of benzonidazole

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Fabio Fernandes

São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Chagas Disease; Fibrosis; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Fabio Fernandes, Md, PHD

  Heart Institute, University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Fernandes, MD, PHD

CONTACT

+55 11 2661 5057; fabio.fernandes@incor.usp.br

Paula Buck, PHD

CONTACT

+55 11 2661 5346; carpaula@incor.usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 12, 2018
• Study Start: October 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: January 5, 2021
• Last Updated: March 11, 2019

Record last verified: 2018-09

Locations

BR (1)