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Evaluation and predictive factors of cardiovascular toxicity associated with hematopoietic stem cell transplantation in malignant hematological diseases

Evaluation and predictive factors of cardiovascular toxicity associated with hematopoietic stem cell transplantation in malignant hematological diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093224
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-08-22
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hematological malignancies

Interventions

Case series :None

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. According to the 4th edition of the Diagnosis and Treatment Standards for Hematological Diseases and the 9th edition of Williams Hematology, patients who meet the criteria for lymphoma, myeloma, acute leukemia, or myelodysplastic syndrome. 2. With normal function of major organs, baseline indications and basic requirements for transplantation, patients who undergo autologous or allogeneic hematopoietic stem cell transplantation. 3. Aged between 16 and 70 years old; 4. ECOG score <=2; 5. Patients with an expected survival period of more than 6 months; 6. Voluntarily join this study, sign informed consent form, comply well, and receive follow-up visits on time.

Exclusion criteria

Exclusion criteria: 1.Pregnant women; Or a woman of childbearing age has a positive blood/urine pregnancy test, and the woman of childbearing age and her spouse are unwilling to use effective contraception during the clinical study period and for 6 months after the end of the clinical study; 2. Left ventricular ejection fraction (LVEF) <=45% on cardiac function assessment prior to transplantation or severe cardiac disease that precludes chemotherapy; 3. Seriously impaired renal function patients, calculated glomerular filtration rate (GFR) <15 ml/min×min2 by MDRD formula or long-term dialysis patients; 4. Patients who have had a serious cardiovascular adverse event within the past 6 months (acute myocardial infarction treated with percutaneous intervention or coronary artery bypass grafting).

Design outcomes

Primary

MeasureTime frame
blood routine examination;liver function test;kidney function test;high-sensitivity troponin;N-terminal pro-brain natriuretic peptide;GDF-15;Electrocardiogram ;holter monitor;cardiac uhrasonography;cardiopulmonary exercise testing;

Secondary

MeasureTime frame
blood glucose;serum lipid;

Countries

China

Contacts

Public ContactMa Liangliang

The First Affiliated Hospital of Dalian Medical University

maliangliangdy@163.com+86 411 8363 5963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026