Brazilian Clinical Registry of Heart Transplantation (HESTIA)

June 7, 2024 updated by: Hospital Israelita Albert Einstein

Prospective Clinical Registry of Heart Transplant Patients in Brazil

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

730

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Iascara Wozniak de Campos, PhD
  • Phone Number: +551121514286
  • Email: iascaraw@gmail.com

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652-900
        • Hospital Israelita Albert Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Heart transplant patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart Transplantation
Adults heart transplantation
Other: Non-interventions
Usual care evaluations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined of total hospitalizations and all-causes deaths
Time Frame: 12 months
Incidence of Hospitalization and death
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual components of the primary outcome;
Time Frame: 12 months
Time to occurrence hospitalizations and death
12 months
Incidence of hospitalizations due to infections not related to the primary outcome;
Time Frame: 12 months
Time to occurrence of infections
12 months
Vaccination rate;
Time Frame: 12 months
All vaccines recommended rate
12 months
Incidence of organ rejection;
Time Frame: 12 months
Time to occurrence of organ rejection
12 months
Cardiovascular mortality; Cardiovascular mortality
Time Frame: 12 months
Time to first occurrence of cardiovascular death
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Study Chair: Fernando Bacal, PhD, Heart Transplantation Coordinator - Hospital Albert Einstein
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 25, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 25, 2027

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HESTIA REGISTRY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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