Brazilian Clinical Registry of Heart Transplantation

Not yet recruiting

• Conditions: Heart Transplant Failure and Rejection; Heart Transplant
• Interventions: Other: Non-interventions

• Registration Number: NCT06453148
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief 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

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Start: 2024-08-25
• Primary Completion: 2024-08-31
• Study Completion: 2027-08-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 730

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Transplantation	Non-interventions	Adults heart transplantation

Primary Outcome Measures

Name	Time	Method
Combined of total hospitalizations and all-causes deaths	12 months	Incidence of Hospitalization and death

Secondary Outcome Measures

Name	Time	Method
Incidence of organ rejection;	12 months	Time to occurrence of organ rejection
Incidence of hospitalizations due to infections not related to the primary outcome;	12 months	Time to occurrence of infections
Cardiovascular mortality; Cardiovascular mortality	12 months	Time to first occurrence of cardiovascular death
Individual components of the primary outcome;	12 months	Time to occurrence hospitalizations and death
Vaccination rate;	12 months	All vaccines recommended rate

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil