Brazilian Clinical Registry of Heart Transplantation

Heart Transplant Clinical Trial

— HESTIA  

Official title:

Prospective Clinical Registry of Heart Transplant Patients in Brazil

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453148
• Other study ID #: HESTIA REGISTRY
• Status: Not yet recruiting
• Start date: August 25, 2024
• Est. completion date: August 25, 2027

Study information

• Verified date: May 2024
• Source: Hospital Israelita Albert Einstein
• Contact: Iascara Wozniak de Campos, PhD
• Phone: +551121514286
• Email: iascaraw[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 730
• Est. completion date: August 25, 2027
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplant
• Heart Transplant Failure and Rejection

Intervention

Other:
• Non-interventions
Usual care evaluations

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined of total hospitalizations and all-causes deaths	Incidence of Hospitalization and death	12 months
Secondary	Individual components of the primary outcome;	Time to occurrence hospitalizations and death	12 months
Secondary	Incidence of hospitalizations due to infections not related to the primary outcome;	Time to occurrence of infections	12 months
Secondary	Vaccination rate;	All vaccines recommended rate	12 months
Secondary	Incidence of organ rejection;	Time to occurrence of organ rejection	12 months
Secondary	Cardiovascular mortality; Cardiovascular mortality	Time to first occurrence of cardiovascular death	12 months