Chronic Chagasic MyocarditisPhase 2NCT02154269

Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy

A Phase 2 study testing Treatment with G-CSF (Granulocyte colony stimulating factor) in people with Chronic Chagasic Myocarditis, run by Hospital Sao Rafael at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Chronic Chagasic Myocarditis
What is being tested?: Treatment with G-CSF (Granulocyte colony stimulating factor)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteBrazil
Study dates: Sep 2015to Jun 2020
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies;
Diagnosis of Chagas' cardiomyopathy in NYHA functional classes II, III and IV of heart failure;
Availability and willingness to participate, given the schedule of the study;
Agreement and signing the written form.

Who cannot join

Acute systemic infections
Solid neoplasms, myelodysplastic syndrome, acute or chronic myeloid leukemia, confirmed by imaging studies or past medical history;
Valvulopathies with hemodynamic consequences;
Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history;
Severe renal, hepatic or thyroid dysfunction, confirmed by imaging studies or past medical history;
Pregnancy (confirmed by examination of β HCG) or lactation;
Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital São Rafael
Salvador, Estado de Bahia, 41253-190

Other trials in Brazil

About this study

Official title: Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy

The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.

Conditions: Chronic Chagasic Myocarditis
Being tested: Treatment with G-CSF (Granulocyte colony stimulating factor), Placebo saline
Keywords: Chagas disease, G-CSF, Cell therapy
Medical subject headings: Chagas Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment with G-CSF (Granulocyte colony stimulating factor)Drug
Also called G-CSF
Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.
Placebo salineDrug
Also called Saline
Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.

Study groups in NCT02154269
Study group	Role	What they receive
G-CSF	Experimental	Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles. Receives: Drug: Treatment with G-CSF (Granulocyte colony stimulating factor)
Saline	Placebo comparator	Subjects will be randomly assigned to receive saline for five days, during 4 cicles. Receives: Drug: Placebo saline

What is being measured

The primary outcome is the main question the study is designed to answer.

NYHA (New York Heart Association) functional class improvement
All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure.
Measured: 6, 9 and 12 months after the therapy with G-CSF

Secondary outcomes (5)

Assessment of cardiovascular function measured by transthoracic echocardiography
All patients will be submitted to echocardiography after 6 and 12 months to assess improvements on ventricular function.
Measured: 6 and 12 months after the therapy
Assessment of cardiovascular function measured by cardiac magnetic resonance imaging
All patients will be submitted to a second cardiac magnetic resonance, after 12 months, to assess improvements on left ventricular ejection fraction.
Measured: 12 months after therapy
Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test
All patients will be submitted to a second treadmill test and 6-minute walk test after 12 months to assess improvement on functional capacity.
Measured: 12 months after the therapy
Evaluation of improvement of quality of life
All patients will respond to Minnesota Questionnaire to have an evaluation of quality of life after 6 and 12 months.
Measured: 6 and 12 months after the therapy
Determination of tolerability
All patients will be submitted to complete blood counts in several time frames in order to evaluate tolerability to G-CSF injection.
Measured: 1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Jun 2020

First posted3 Jun 2014 (estimated)
Study startSep 2015
Primary completionOct 2019
Study completionJun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Chagasic MyocarditisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02154269
Sponsor's protocol ID: PCL07/12
Status last verified: Aug 2020
First submitted: 30 May 2014
Last updated: 24 Aug 2020
Results posted: No
Data monitoring committee: Yes

Publications

Macedo CT, Larocca TF, Noya-Rabelo M, Aras R Jr, Macedo CRB, Moreira MI, Caldas AC, Torreao JA, Monsao VMA, Souza CLM, Vasconcelos JF, Bezerra MR, Petri DP, Souza BSF, Pacheco AGF, Daher A, Ribeiro-Dos-Santos R, Soares MBP. Efficacy and Safety of Granulocyte-Colony Stimulating Factor Therapy in Chagas Cardiomyopathy: A Phase II Double-Blind, Randomized, Placebo-Controlled Clinical Trial. Front Cardiovasc Med. 2022 Jun 9;9:864837. doi: 10.3389/fcvm.2022.864837. eCollection 2022.
PubMed 35757326

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy
ClinicalTrials.gov ID: NCT02154269
Acronym / sponsor ID: PCL07/12
Conditions: Chronic Chagasic Myocarditis
Keywords: Chagas disease, G-CSF, Cell therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Hospital Sao RafaelUniversity, hospital or other
Study start: Sep 2015 (actual)
Primary completion: Oct 2019 (actual)
Study completion: Jun 2020 (actual)
First posted: 3 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
G-CSF	Experimental	Drug: Treatment with G-CSF (Granulocyte colony stimulating factor)Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.
Saline	Placebo comparator	Drug: Placebo salineSubjects will be randomly assigned to receive saline for five days, during 4 cicles.

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies;
Diagnosis of Chagas' cardiomyopathy in NYHA functional classes II, III and IV of heart failure;
Availability and willingness to participate, given the schedule of the study;
Agreement and signing the written form.

Key exclusion criteria (7 listed)

Acute systemic infections
Solid neoplasms, myelodysplastic syndrome, acute or chronic myeloid leukemia, confirmed by imaging studies or past medical history;
Valvulopathies with hemodynamic consequences;
Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history;
Severe renal, hepatic or thyroid dysfunction, confirmed by imaging studies or past medical history;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment with G-CSF (Granulocyte colony stimulating factor)Also: G-CSFSubjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.	Drug	G-CSF
Placebo salineAlso: SalineSubjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.	Drug	Saline

Primary outcome

NYHA (New York Heart Association) functional class improvement
Time frame: 6, 9 and 12 months after the therapy with G-CSF
All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure.

5 secondary outcomes

Assessment of cardiovascular function measured by transthoracic echocardiography
Time frame: 6 and 12 months after the therapy
Assessment of cardiovascular function measured by cardiac magnetic resonance imaging
Time frame: 12 months after therapy
Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test
Time frame: 12 months after the therapy
Evaluation of improvement of quality of life
Time frame: 6 and 12 months after the therapy
Determination of tolerability
Time frame: 1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
Derived from this study: PubMed 35757326Macedo CT, Larocca TF, Noya-Rabelo M, Aras R Jr, Macedo CRB, Moreira MI, Caldas AC, Torreao JA, Monsao VMA, Souza CLM, Vasconcelos JF, Bezerra MR, Petri DP, Souza BSF, Pacheco AGF, Daher A, Ribeiro-Dos-Santos R, Soares MBP. Efficacy and Safety of Granulocyte-Colony Stimulating Factor Therapy in Chagas Cardiomyopathy: A Phase II Double-Blind, Randomized, Placebo-Controlled Clinical Trial. Front Cardiovasc Med. 2022 Jun 9;9:864837. doi: 10.3389/fcvm.2022.864837. eCollection 2022.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Milena BP Soares, PhD principal investigator

Hospital São Rafael

Ticiana F Larocca, MD, Msc study director

Hospital São Rafael

Ricardo Ribeiro-dos-Santos, PhD study chair

Hospital São Rafael

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Treatment with G-CSF (Granulocyte colony stimulating factor) in people with Chronic Chagasic Myocarditis, run by Hospital Sao Rafael at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NYHA (New York Heart Association) functional class improvement (time frame: 6, 9 and 12 months after the therapy with G-CSF). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02154269, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.