Skip to main content
Clinical Trials/NCT05728788
NCT05728788
Recruiting
Not Applicable

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

Peking University Third Hospital1 site in 1 country50 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Antitumor drugs
Conditions
Cancer Therapy-related Cardiovascular Toxicity
Sponsor
Peking University Third Hospital
Enrollment
50
Locations
1
Primary Endpoint
At least a 10% decrease in the global longitudinal strain
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
December 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Patients treated with antineoplastic agents

50 patients treated with antineoplastic agents will be enrolled.

Intervention: Antitumor drugs

Outcomes

Primary Outcomes

At least a 10% decrease in the global longitudinal strain

Time Frame: 6 months

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

Study Sites (1)

Loading locations...

Similar Trials