Brazilian Clinical Registry of Heart Transplantation

NCT06453148 | Not Yet Recruiting

• 1 other identifier: HESTIA REGISTRY
• Study Type: observational
• Target: 730
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant Failure and Rejection; Heart Transplant

Outcome Measures

Primary Outcomes (1)

• Combined of total hospitalizations and all-causes deaths

  Incidence of Hospitalization and death

  12 months

Secondary Outcomes (5)

• Individual components of the primary outcome;

  12 months

• Incidence of hospitalizations due to infections not related to the primary outcome;

  12 months

• Vaccination rate;

  12 months

• Incidence of organ rejection;

  12 months

• Cardiovascular mortality; Cardiovascular mortality

  12 months

Study Arms (1)

Heart Transplantation

Adults heart transplantation

Other: Non-interventions

Interventions

Non-interventions OTHER

Usual care evaluations

Heart Transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Heart transplant patients

You may qualify if:

• Patients over 18 years old;
• Heart Transplantation within 30 days of both sexes;

You may not qualify if:

• Refusal to provide consent for the study;
• In the judgment of the local investigator, any difficulty accessing follow-up visits

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

Location

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Fernando Bacal, PhD

  Heart Transplantation Coordinator - Hospital Albert Einstein

  STUDY CHAIR

• Henrique A Fonseca, PhD

  Head of Vaccines and Immunobiology Clinical Trial - ARO-EINSTEIN

  PRINCIPAL INVESTIGATOR

• Iascara Wozniak de Campos, PhD

  Clinical Trialist - ARO - EINSTEIN

  PRINCIPAL INVESTIGATOR

• Luiz V Rizzo, PhD

  Director - ARO - EINSTEIN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iascara Wozniak de Campos, PhD

CONTACT

+551121514286; iascaraw@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 11, 2024
• Study Start: August 25, 2024
• Primary Completion: August 31, 2024
• Study Completion (Estimated): August 25, 2027
• Last Updated: June 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)