Brazilian Clinical Registry of Heart Transplantation (HESTIA)

Hospital Israelita Albert Einstein

Status: Not yet enrolling

Conditions: Heart Transplant Failure and Rejection; Heart Transplant

Treatments: Other: Non-interventions

Study type: Observational

Funder types: Other

Identifiers

NCT06453148

HESTIA REGISTRY

Details and patient eligibility

About

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.

Full description

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

Enrollment: 730 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

730 participants in 1 patient group

Heart Transplantation

Description:

Adults heart transplantation

Treatment:

Other: Non-interventions