Brazilian Clinical Registry of Heart Transplantation

NCT ID: NCT06453148

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

730 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-25

Study Completion Date

2027-08-25

Brief Summary

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Prospective cohort clinical study, registry-based, multicenter, national, with the consecutive inclusion of patients with a history of Heart Transplantation in Brazil. The clinical registry will involve the participation until 25 centers. Patients will be included up to 30 days after Heart Transplant surgery and will be followed for one year. Laboratory tests and clinical parameters wil be collected in two clinical visits (6mo and 12 mo). The outcomes evaluate will be the total hospitalizations and all-cause death. It is expected to include 730 patients with a 12-month follow-up from the day of the transplant surgery. The findings of the HESTIA Registry may guide the management of post-heart transplant patients, aiming at reducing morbidity and mortality within 12 months after heart transplant surgery.

Detailed Description

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The study will include participants who have undergone heart transplantation at transplant centers across Brazil. Patients will be enrolled within the first 30 days after surgery and will be followed for one year.

The study will be participant-centered through clinical visits. There will be an admission visit and two additional visits: one at 6 months (V1) and another at 12 months (V2), which will be the closing visit

Conditions

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Heart Transplant Failure and Rejection Heart Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Transplantation

Adults heart transplantation

Non-interventions

Intervention Type OTHER

Usual care evaluations

Interventions

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Non-interventions

Usual care evaluations

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years old;
* Heart Transplantation within 30 days of both sexes;

Exclusion Criteria

* Refusal to provide consent for the study;
* In the judgment of the local investigator, any difficulty accessing follow-up visits
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando Bacal, PhD

Role: STUDY_CHAIR

Heart Transplantation Coordinator - Hospital Albert Einstein

Henrique A Fonseca, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of Vaccines and Immunobiology Clinical Trial - ARO-EINSTEIN

Iascara Wozniak de Campos, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trialist - ARO - EINSTEIN

Luiz V Rizzo, PhD

Role: PRINCIPAL_INVESTIGATOR

Director - ARO - EINSTEIN

Locations

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Hospital Israelita Albert Einstein

São Paulo, , Brazil

Site Status

Countries

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Brazil

Central Contacts

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Iascara Wozniak de Campos, PhD

Role: CONTACT

+551121514286

Other Identifiers

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HESTIA REGISTRY

Identifier Type: -

Identifier Source: org_study_id

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