Prospective Clinical Registry of Heart Transplant Patients in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- Combined of total hospitalizations and all-causes deaths
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old;
- •Heart Transplantation within 30 days of both sexes;
排除标准
- •Refusal to provide consent for the study;
- •In the judgment of the local investigator, any difficulty accessing follow-up visits
结局指标
主要结局
Combined of total hospitalizations and all-causes deaths
时间窗: 12 months
Incidence of Hospitalization and death
次要结局
- 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)