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

Recruiting

• Conditions: Cancer Therapy-related Cardiovascular Toxicity
• Interventions: Drug: Antitumor drugs

• Registration Number: NCT05728788
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with antineoplastic agents	Antitumor drugs	50 patients treated with antineoplastic agents will be enrolled.

Primary Outcome Measures

Name	Time	Method
At least a 10% decrease in the global longitudinal strain	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.

Trial Locations

Locations (1)

Zhenyu Tian; 🇨🇳 Beijing, China