Early Identification and Evaluation of Cyclophosphamide Cardiotoxicity

NCT05150080 | Unknown

• 1 other identifier: QianfoshanH-210118
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hematopoietic stem cell transplantation is an important method for the treatment of hematological diseases and cyclophosphamide is a commonly used chemotherapeutic agent for transplant pretreatment. The incidence of severe cardiovascular events after high-dose cyclophosphamide exposure ranges from 7% to 28% with mortality from 11% to 43%. Thus, an non-invasive, sensitive and reliable method in detecting cardiac function is significant to balance the cardiac risk and the potential cancer treatment benefits. In previous studies, we demonstrated that strain values analyzed by speckle tracking echocardiography decreased significantly after high-dose cyclophosphamide exposure, even though left ventricular ejection fraction remained stable and within normal range. We follow up the hematopoietic cell transplantation patients with cyclophosphamide: to analyze the cut-off values of the parameters of speckle tracking multilayer analysis in predicting early cardiotoxicity induced by cyclophosphamide; to detect the cut-off values of the plasma miRNAs levels in predicting early cardiotoxicity induced by anthracycline. The purpose of our study is to find out non-invasive, reliable and sensitive echocardiographic parameters and plasma biomarkers for early detection and prediction cyclophosphamide -induced cardiac toxicity and to be helpful to target patients at high risk of cardiotoxicity, who could benefit from closer monitoring or earlier initiation of cardioprotective therapy.

Conditions

Cardio-oncology; Hematopoietic Stem Cell Transplantation; Cardiotoxicity; Cyclophosphamide; Echocardiography

Keywords

Cardio-oncology; Speckle tracking echocardiography

Outcome Measures

Primary Outcomes (1)

• changes of global longitudinal strain value between cardiotoxicity group and No cardiotoxicity

  changes of global longitudinal strain value between cardiotoxicity group and No cardiotoxicity at the follow-up point

  From the start of cyclophosphamide injection to1 month after the completion of injection

Secondary Outcomes (1)

• changes of miRNA between cardiotoxicity group and No cardiotoxicity

  From the start of cyclophosphamide injection to1 month after the completion of injection

Study Arms (2)

cardiotoxicity

subjects with heart failure, coronary artery disease, valvular heart disease, arrhythmia, hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension and pericardial disease after hematopoietic stem cell transplantation.

non-cardiotoxicity

subjects with on heart failure, coronary artery disease, valvular heart disease, arrhythmia, hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension and pericardial disease after hematopoietic stem cell transplantation.

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hematopoietic stem cell transplantation received high dose cyclophosphamide(\>120mg/kg)

You may qualify if:

• Age ≤14 years old;
• Bone marrow/umbilical blood HCT received high dose cyclophosphamide(\>120mg/kg) ；
• ECOG≤2;
• Sign an informed consent form (\<10 years old, signed by the guardian; ≥10 years old, signed by the child and guardian).

You may not qualify if:

• Past myocarditis, cardiomyopathy, valvular heart disease, rheumatic heart disease, severe arrhythmia, heart failure, congenital heart disease history;
• Have heart or pericardial surgery;
• Have received radiotherapy involving thoracic cavity；
• Those who do not meet the above entry criteria.

Sponsors & Collaborators

• Kai Mu: lead

Study Sites (1)

Qianfoshan Hospital (The First Affiliated Hospital of Shandong First Medical University)

Jinan, Shandong, 251400, China

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• MU Kai

  Qianfoshan Hospital

  STUDY CHAIR

Central Study Contacts

MU Kai

CONTACT

15634883957; mkbest@yeah.net

ZHANG Jing

CONTACT

13066036057

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Assistant

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 8, 2021
• Study Start: July 10, 2021
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

CN (1)