Clinical trial NCT05775432: Prognosis of Heart Transplanted Patients With Heart Failure
Official title: Prognosis of Heart Transplanted Patients With Heart Failure (RE-START): a National Multi-center, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Heart transplantation
Heart failure
Prognosis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation are enrolled into heart transplantation group. Individuals whose hearts are donated are enrolled into control group.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the incidence of all-cause death
timeFrame: In-hospital (an average of 1 month), 1, 2, 3, 5, 10, 15 and 20 years after heart transplantation.
Secondary outcomes:
measure: Use of advanced life support (ALS)
timeFrame: In-hospital (an average of 1 month)
measure: Incidence of postoperative complications
timeFrame: In-hospital (an average of 1 month)
measure: ICU admission time
timeFrame: In-hospital (an average of 1 month)
measure: Change of cardiac function index
timeFrame: In-hospital (an average of 1 month).
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References: