Brazilian Clinical Registry of Heart Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-interventions.
- Who it may be relevant to
- Registry conditions: Heart Transplant Failure and Rejection, Heart Transplant. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Clinical Registry of Heart Transplant Patients in Brazil
Overview
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
Interventions
- Other Non-interventions
Usual care evaluations
Primary outcome measures
- Combined of total hospitalizations and all-causes deaths [Time frame: 12 months]
Secondary outcome measures (5)
- Individual components of the primary outcome; [Time frame: 12 months]
- Incidence of hospitalizations due to infections not related to the primary outcome; [Time frame: 12 months]
- Vaccination rate; [Time frame: 12 months]
- Incidence of organ rejection; [Time frame: 12 months]
- Cardiovascular mortality; Cardiovascular mortality [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Hospital Israelita Albert Einstein — São Paulo
Identifiers
NCT: NCT06453148 · HESTIA REGISTRY