Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453148
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-07
Brief Title:
Brazilian Clinical Registry of Heart Transplantation
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Prospective Clinical Registry of Heart Transplant Patients in Brazil
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HESTIA
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None