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NCT Number: NCT06453148

Brazilian Clinical Registry of Heart Transplantation

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.

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Key information

Conditions

Heart Transplant Failure and Rejection Behavior Heart Transplant Rejection, Psychology Social Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-interventions

Other

Usual care evaluations

Primary outcomes

  1. Combined of total hospitalizations and all-causes deaths

    Time frame: 12 months

    Incidence of Hospitalization and death

Secondary outcomes

  1. Individual components of the primary outcome;

    Time frame: 12 months

    Time to occurrence hospitalizations and death

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

    Time frame: 12 months

    Time to occurrence of infections

  3. Vaccination rate;

    Time frame: 12 months

    All vaccines recommended rate

  4. Incidence of organ rejection;

    Time frame: 12 months

    Time to occurrence of organ rejection

  5. Cardiovascular mortality; Cardiovascular mortality

    Time frame: 12 months

    Time to first occurrence of cardiovascular death

Study contacts

Contact information is provided by the study sponsor or research team.

Iascara Wozniak de Campos, PhD

CONTACT

[email protected]

+551121514286

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

Prospective Clinical Registry of Heart Transplant Patients in Brazil

Acronym: HESTIA

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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