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Heart Transplant Failure and RejectionHESTIANCT06453148

Brazilian Clinical Registry of Heart Transplantation

An observational study of Heart Transplant Failure and Rejection and Heart Transplant, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Non-interventions
How many people
730 participants
Where
1 siteBrazil
Study dates
25 Aug 2024to 25 Aug 2027
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Heart transplant patients

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iascara Wozniak de Campos, PhD contact

+551121514286

iascaraw@gmail.com

Brazil1 site

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900

Other trials in Brazil

About this study

Official title: 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.

Read the 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

Being tested
Non-interventions
Medical subject headings
Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-interventionsOther

    Usual care evaluations

Study groups in NCT06453148
Study groupRoleWhat they receive
Heart TransplantationAdults heart transplantation
Receives: Other: Non-interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined of total hospitalizations and all-causes deaths

    Incidence of Hospitalization and death

    Measured: 12 months

Secondary outcomes (5)

  1. Individual components of the primary outcome;

    Time to occurrence hospitalizations and death

    Measured: 12 months

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

    Time to occurrence of infections

    Measured: 12 months

  3. Vaccination rate;

    All vaccines recommended rate

    Measured: 12 months

  4. Incidence of organ rejection;

    Time to occurrence of organ rejection

    Measured: 12 months

  5. Cardiovascular mortality; Cardiovascular mortality

    Time to first occurrence of cardiovascular death

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start25 Aug 2024 (estimated)
  3. Primary completion31 Aug 2024 (estimated)
  4. Study completion25 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
730 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06453148
Sponsor's protocol ID
HESTIA REGISTRY
Acronym
HESTIA
Status last verified
May 2024
First submitted
7 Jun 2024
Last updated
11 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Transplant Failure and Rejection and Heart Transplant, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Iascara Wozniak de Campos, PhD (+551121514286, iascaraw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined of total hospitalizations and all-causes deaths (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06453148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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