Prognosis of Heart Transplanted Patients With Heart Failure

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart transplantation group<br>Patients with heart failure of different etiologies undergoing heart transplant. | |
| Control group<br>Individuals whose hearts are donated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the incidence of all-cause death | Death from any cause in patients after heart transplantation, will be assessed from medical records. | In-hospital (an average of 1 month), 1, 2, 3, 5, 10, 15 and 20 years after heart transplantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of advanced life support (ALS) | Duration of ALS after heart transplantation, will be assessed from medical records. | In-hospital (an average of 1 month) | 
| Incidence of postoperative complications | Postoperative complications after heart transplantation will be assessed from medical records. | In-hospital (an average of 1 month) | 
| ICU admission time | ICU admission time after heart transplantation, will be assessed from medical records. | In-hospital (an average of 1 month) | 
| Change of cardiac function index | Cardiac functional index after heart transplantation will be assessed by transthoracic echocardiography. | In-hospital (an average of 1 month). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart transplantation, Heart failure, Prognosis