Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation (CORE-HCT)

January 9, 2026 updated by: Xiao Hui Zhang, Peking University People's Hospital

Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation (CORE-HCT): A Prospective Multicenter Observational Study

This is a prospective, multicenter observational study for recipients of hematopoietic stem cell transplantation. Patients who underwent hematopoietic stem cell transplantation at the participating centers will be entrolled in the study. The clinical characteristics, laboratory profiles, management measures, and clinical outcomes such as post-transplant cardiovascular events will be prospectively collected.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Yu Jun Dong
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Hong Mei Jing
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Dai Hong Liu
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Xinqiao hospital of the third military medical university
        • Contact:
          • Xi Zhang
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center, Sun Yat-sen University
        • Contact:
          • Yang Liang
      • Shenzhen, Guangdong, China
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
          • Hong Yu Zhang
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • First Affiliated Hospital of Harbin Medical University
        • Contact:
          • Sheng Jin Fan
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Zhong Xing Jiang
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Ling Hui Xia
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Yi Cheng Zhang
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • First Affiliated Hospital Xi'an Jiaotong University
        • Contact:
          • Peng Cheng He
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Xiao Bing Huang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)
        • Contact:
          • Er Lie Jiang
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Ming Jiang
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Zhejiang University
        • Contact:
          • Yi Luo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.

Description

Inclusion Criteria:

  • Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.

Exclusion Criteria:

  • Any other conditions that, in the opinion of the investigator, can interfere with the interpretation of data.
  • Patient request to withdraw from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing hematopoietic stem cell transplantation
Patients who undergo allogeneic hematopoietic stem cell transplantation at participating medical center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE)
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Major adverse cardiovascular events (MACE) after hematopoietic stem cell transplantation.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Cardiovascular events after hematopoietic stem cell transplantation, such as cardiovascular death, ischemic heart disease, coronary artery disease, stroke, heart failure, arrhythmia cardiomyopathy, myocarditis, endocarditis, valvular heart disease, and pericardial disease.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Overall survival
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Overall survival after hematopoietic stem cell transplantation.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Event-free survival
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Events were defined as the occurrence of any of the following after allo-HSCT: grade III-IV acute graft-versus-host disease (GVHD), chronic GVHD requiring systemic immunosuppression, relapse or progression of the hematologic disease, or death from any cause during follow-up.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Complications of hematopoietic stem cell transplantation
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Complications arising from hematopoietic stem cell transplantation range from early issues such as regimen toxicity and acute GVHD to late effects including chronic GVHD, organ dysfunction, and secondary malignancies.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Peking University First Hospital
Chinese PLA General Hospital
Peking University Third Hospital
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Zhengzhou University
Peking University Shenzhen Hospital
First Affiliated Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
First Affiliated Hospital of Harbin Medical University
Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)
Sun Yat-sen University Cancer Center, Sun Yat-sen University
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Xinqiao hospital of the third military medical university
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 30, 2036

Study Completion (Estimated)

December 31, 2036

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-z232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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