Heart Transplant, Heart Transplant Failure and Rejection
Conditions
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
Interventions
OTHERNon-interventions
Usual care evaluations
Sponsors
Hospital Israelita Albert Einstein
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined of total hospitalizations and all-causes deaths | 12 months | Incidence of Hospitalization and death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hospitalizations due to infections not related to the primary outcome; | 12 months | Time to occurrence of infections |
| Vaccination rate; | 12 months | All vaccines recommended rate |
| Incidence of organ rejection; | 12 months | Time to occurrence of organ rejection |
| Individual components of the primary outcome; | 12 months | Time to occurrence hospitalizations and death |
| Cardiovascular mortality; Cardiovascular mortality | 12 months | Time to first occurrence of cardiovascular death |
Countries
Brazil
Contacts
Primary ContactIascara Wozniak de Campos, PhD
Outcome results
None listed