Prospective Clinical Registry of Heart Transplant Patients in Brazil
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Transplant Failure and Rejection
- Sponsor
- Hospital Israelita Albert Einstein
- Enrollment
- 730
- Locations
- 1
- Primary Endpoint
- Combined of total hospitalizations and all-causes deaths
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Combined of total hospitalizations and all-causes deaths
Time Frame: 12 months
Incidence of Hospitalization and death
Secondary Outcomes
- Incidence of organ rejection;(12 months)
- Incidence of hospitalizations due to infections not related to the primary outcome;(12 months)
- Cardiovascular mortality; Cardiovascular mortality(12 months)
- Individual components of the primary outcome;(12 months)
- Vaccination rate;(12 months)