Clinical trial NCT06453148: Brazilian Clinical Registry of Heart Transplantation
Official title: Prospective Clinical Registry of Heart Transplant Patients in Brazil
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Transplant Failure and Rejection
Heart Transplant
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart transplant patients

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

Eligibility criteria: 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

Primary outcomes:
measure: Combined of total hospitalizations and all-causes deaths
timeFrame: 12 months
Secondary outcomes:
measure: Individual components of the primary outcome;
timeFrame: 12 months
measure: Incidence of hospitalizations due to infections not related to the primary outcome;
timeFrame: 12 months
measure: Vaccination rate;
timeFrame: 12 months
measure: Incidence of organ rejection;
timeFrame: 12 months
measure: Cardiovascular mortality; Cardiovascular mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Heart Transplantation Coordinator - Hospital Albert Einstein
name: Fernando Bacal, PhD
role: STUDY_CHAIR
affiliation: Head of Vaccines and Immunobiology Clinical Trial - ARO-EINSTEIN
name: Henrique A Fonseca, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Trialist - ARO - EINSTEIN
name: Iascara Wozniak de Campos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director - ARO - EINSTEIN
name: Luiz V Rizzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: