Prognosis of Heart Transplanted Patients for Heart Failure (RE-START)

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05775432
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 237.6
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Procedure: Heart Transplant

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Prognosis of Heart Transplanted Patients for Heart Failure (RE-START): a National Multi-center, Cohort Study
• Anticipated Study Start Date: Mar 15, 2023
• Anticipated Primary Completion Date: Dec 31, 2042
• Anticipated Study Completion Date: Dec 31, 2042

Arms and Interventions

Arm	Intervention/Treatment
Heart Transplant Group Patients with heart failure of different etiologies undergoing heart transplant.	Procedure: Heart Transplant; 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.
Control group Donor hearts were included as biological control controls.

Outcome Measures

Primary Outcome Measures

1. In-hospital mortality [up to 6 months in hospital]

   In-hospital mortality in patients after heart transplantation

2. Survival rate [within 6 months after surgery.]

   Survival rates of patients at different follow-up times

3. Survival rate [within 1 year after surgery.]

   Survival rates of patients at different follow-up times

4. Survival rate [within 2 years after surgery.]

   Survival rates of patients at different follow-up times

5. Survival rate [within 3 years after surgery.]

   Survival rates of patients at different follow-up times

6. Survival rate [within 5 years after surgery.]

   Survival rates of patients at different follow-up times

7. Survival rate [within 10 years after surgery.]

   Survival rates of patients at different follow-up times

8. Survival rate [within 15 years after surgery.]

   Survival rates of patients at different follow-up times

9. Survival rate [within 20 years after surgery.]

   Survival rates of patients at different follow-up times

Secondary Outcome Measures

1. Use of ECMO ratio [up to 6 months in hospital]

   Proportion of patients on ECMO preoperatively

2. Use of CRRT ratio [up to 6 months in hospital]

   Proportion of patients on CRRT preoperatively

3. Use of IABP ratio [up to 6 months in hospital]

   Proportion of patients on IABP preoperatively

4. Duration of mechanical ventilation [up to 6 months in hospital]

   Duration of postoperative mechanical ventilation

5. Prevelence of postoperative complications [up to 6 months in hospital]

   Prevelence of postoperative complications (including secondary tracheal intubation, tracheotomy, secondary chest opening, infection, cardiac arrest, and other significant organ damage and vascular lesions of allogeneic heart grafts)

6. Post-operative ICU admission time [up to 6 months in hospital]

   Post-operative ICU admission time

7. Cardiac function index [at discharge, up to 6 months in hospital]

   Cardiac functional index at discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with end-stage heart failure presented to our hospital who were evaluated by clinicians and ethically approved for heart transplantation

Exclusion Criteria:

• Patients refuse to sign informed consent form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

• First Affiliated Hospital Xi'an Jiaotong University

Investigators

• Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT05775432
• Other Study ID Numbers: XJTU1AF2023LSK-152
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by First Affiliated Hospital Xi'an Jiaotong University: Heart transplant; Heart Failure
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Mar 20, 2023