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Brazilian Clinical Registry of Heart Transplantation

ConditionsHeart Transplant Failure and RejectionHeart Transplant
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHospital Israelita Albert Einstein

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years old;

Heart Transplantation within 30 days of both sexes;

Disqualifiers

Refusal to provide consent for the study;

In the judgment of the local investigator, any difficulty accessing follow-up visits

Trial population

Heart transplant patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-interventions

    Other intervention

    Usual care evaluations

Treatment groups

730 Participants
are divided into 1 treatment group
Group A: Heart Transplantation1 intervention

Trial outcomes

Primary outcomes

1

Combined of total hospitalizations and all-causes deaths

Incidence of Hospitalization and death

Time frame
12 months

Secondary outcomes

1

Individual components of the primary outcome;

Time to occurrence hospitalizations and death

Time frame
12 months
2

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

Time to occurrence of infections

Time frame
12 months
3

Vaccination rate;

All vaccines recommended rate

Time frame
12 months
4

Incidence of organ rejection;

Time to occurrence of organ rejection

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Israelita Albert Einstein

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: