NCT06453148

Brazilian Clinical Registry of Heart Transplantation

Prospective Clinical Registry of Heart Transplant Patients in Brazil

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 730 (estimated)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Heart Transplant Failure and Rejection
• Heart Transplant

Interventions

Type	Name	Description
OTHER	Non-interventions	Usual care evaluations

Timeline

• Start date: 2024-08-25
• Primary completion: 2024-08-31
• Completion: 2027-08-25
• First posted: 2024-06-11
• Last updated: 2024-06-11

Locations

1 site across 1 country: Brazil