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Brazilian Clinical Registry of Heart Transplantation

NCT06453148 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 730

Last updated 2024-06-11

No results posted yet for this study

Summary

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.

Conditions

  • Heart Transplant Failure and Rejection
  • Heart Transplant

Interventions

OTHER

Non-interventions

Usual care evaluations

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Fernando Bacal, PhD · Heart Transplantation Coordinator - Hospital Albert Einstein

  • Henrique A Fonseca, PhD · Head of Vaccines and Immunobiology Clinical Trial - ARO-EINSTEIN

  • Iascara Wozniak de Campos, PhD · Clinical Trialist - ARO - EINSTEIN

  • Luiz V Rizzo, PhD · Director - ARO - EINSTEIN

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-25
Primary Completion
2024-08-31
Completion
2027-08-25

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453148 on ClinicalTrials.gov