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NCT Number: NCT05775432

Prognosis of Heart Transplanted Patients With Heart Failure

Heart transplantation is the most effective treatment for end-stage heart failure, advanced cardiomyopathy, and complex congenital heart disease with severe heart failure or hypoxia. Several clinical studies have shown significant differences in the prognosis of heart transplantation patients with different etiologies, and post-transplantation complications are an important factor affecting patient survival, and there is still a lack of overall prognostic stratification and extensive clinical studies on risk factors after heart transplantation. Therefore, this study is intended to include patients who underwent heart transplantation for different etiologies of heart failure, collect clinical data and biological samples from patients, and use various techniques to deeply interpret the risk factors affecting the prognosis of heart transplantation patients and construct a prognostic prediction model to provide specific and individualized treatment ideas and theoretical basis for improving the survival rate of patients after heart transplantation.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

3 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation
  • Individuals whose hearts are donated

Exclusion criteria

  • Patients refuse to sign informed consent form

Treatment and study plan

Primary outcomes

  1. Change in the incidence of all-cause death

    Time frame: In-hospital (an average of 1 month), 1, 2, 3, 5, 10, 15 and 20 years after heart transplantation.

    Death from any cause in patients after heart transplantation, will be assessed from medical records.

Secondary outcomes

  1. Use of advanced life support (ALS)

    Time frame: In-hospital (an average of 1 month)

    Duration of ALS after heart transplantation, will be assessed from medical records.

  2. Incidence of postoperative complications

    Time frame: In-hospital (an average of 1 month)

    Postoperative complications after heart transplantation will be assessed from medical records.

  3. ICU admission time

    Time frame: In-hospital (an average of 1 month)

    ICU admission time after heart transplantation, will be assessed from medical records.

  4. Change of cardiac function index

    Time frame: In-hospital (an average of 1 month).

    Cardiac functional index after heart transplantation will be assessed by transthoracic echocardiography.

Study contacts

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

Guoliang Li

CONTACT

[email protected]

+8613759982523

Yang Yan

CONTACT

[email protected]

+862985323865

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Prognosis of Heart Transplanted Patients With Heart Failure (RE-START): a National Multi-center, Retrospective-prospective, Cohort Study

Acronym: RE-START

Important dates

Study start
2023
Primary completion
2042
Study completion
2042
First posted
Mar 20, 2023
Registry last updated
Jul 12, 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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