Prognosis of Heart Transplanted Patients With Heart Failure

Heart Failure Clinical Trial

— RE-START  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05775432
• Other study ID #: XJTU1AF2023LSK-391
• Status: Not yet recruiting
• Start date: December 31, 2024
• Est. completion date: December 31, 2042

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang Li
• Phone: +8613759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2042
• Est. primary completion date: December 31, 2042
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Incidence of postoperative complications	Postoperative complications after heart transplantation will be assessed from medical records.	In-hospital (an average of 1 month)
Secondary	ICU admission time	ICU admission time after heart transplantation, will be assessed from medical records.	In-hospital (an average of 1 month)
Secondary	Change of cardiac function index	Cardiac functional index after heart transplantation will be assessed by transthoracic echocardiography.	In-hospital (an average of 1 month).