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Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy

Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05728788
Enrollment
50
Registered
2023-02-15
Start date
2022-07-01
Completion date
2023-12-01
Last updated
2023-03-03

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

Conditions

Cancer Therapy-related Cardiovascular Toxicity

Brief summary

The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection.

Detailed description

This is a monocentric prospective cohort study in which 50 patients treated for malignant tumors will be included. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation.

Interventions

DRUGAntitumor drugs

Anthracyclines, immune checkpoint inhibitors, monoclonal antibodies, and tyrosine kinase inhibitors

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* With malignant tumors * Will receive antitumor drugs * Could receive regular follow-up for 6 months * Written informed consent

Exclusion criteria

* Satisfactory echocardiographic images could not be obtained * Cardiomyopathy * Coronary artery disease * Heart failure * Arrhythmia requiring intervention * Moderate or severe valvular disease * Acute myocarditis * Refractory hypertension * Participating in other studies of drug intervention

Design outcomes

Primary

MeasureTime frameDescription
At least a 10% decrease in the global longitudinal strain6 monthsThe primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE and compared with baseline.

Countries

China

Contacts

Primary ContactZhenyu Tian, Doctor
tzy003@126.com+8613051871220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026