Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload

October 27, 2024 updated by: Xiaozheng Zhou, Beijing Anzhen Hospital

"Bicuspid aortic stenosis represents the most prevalent form of cardiac valve disease, primarily resulting from degenerative alterations and rheumatic conditions that disrupt mitral valve function. This dysfunction exacerbates the hemodynamic burden on the right heart, leading to secondary pulmonary hypertension-a condition uniquely predisposed to myocardial fibrosis. The role of right ventricular (RV) fibrosis in pulmonary hypertension induced by bicuspid aortic stenosis remains an area of active investigation. Modifications in the extracellular matrix collagen network may mitigate excessive dilation of the pressure-overloaded right ventricle; however, fibrosis concurrently compromises cardiac performance. An increasing body of experimental evidence indicates that fibrosis is pivotal in both the onset and progression of right ventricular dysfunction. In cases of secondary pulmonary hypertension, the right ventricle endures a posterior load approximately five times greater than normal, rendering these circumstances an excellent model for examining pressure loading effects on RV structure. Notably, severe RV fibrosis persists even after hemodynamic normalization following mitral valve repair; thus, preoperative evaluation of RV fibrosis is essential for optimizing patient outcomes in individuals with secondary pulmonary hypertension attributable to bicuspid aortic stenosis.

In recent years, myocardial nuclear imaging has gained prominence as a tool for assessing myocardial fibrosis. Initial studies investigated FAPI myocardial nuclear imaging's efficacy in evaluating left ventricular fibrosis among patients with aortic stenosis; subsequent research elucidated its correlation with sudden cardiac death risk in individuals suffering from obstructive hypertrophic cardiomyopathy.

The comprehension regarding how myocardial fibrosis impacts right ventricular function within patients experiencing pulmonary hypertension due to bicuspid aortic stenosis remains limited. The association between histological RV fibrosis and adverse prognostic indicators as well as outcomes related to right heart failure warrants further exploration."

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • FAPI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study was performed in patients with volumetric right ventricular dysfunction. To evaluate the right ventricular function in patients with valvular heart disease and optimize the condition detection and volume therapy in patients with right ventricular dysfunction.

Description

Inclusion Criteria:

Clinical diagnosis of Tricuspid valve insufficiency; must understand the purpose of the study and signed an informed consent form;

Exclusion Criteria:

Combined coronary artery stenosis; Combined with aortic aneurysm related diseases; Patients with congenital heart disease;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
high-FAPI+
FAPI Nuclear Medicine Cardiac Imaging stronge Positive" in English.
Diagnostic test: Diagnose the patient's right heart function as well as right heart fibrosis
Diagnose the patient's right heart function as well as right heart fibrosis
low-FAPI+
FAPI Nuclear Medicine Cardiac Imaging Weak Positive" in English.
Diagnostic test: Diagnose the patient's right heart function as well as right heart fibrosis
Diagnose the patient's right heart function as well as right heart fibrosis
No FAPI+
FAPI nuclear medicine cardiac imaging negative
Other: Diagnose the patients right heart function as well as right heart fibrosis
Diagnose the patients right heart function as well as right heart fibrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right heart dysfunction
Time Frame: 15 days
Central venous pressure（cmH2O）
15 days
Right heart dysfunction
Time Frame: 3 mouths
P-V Curve of curve（cmH2O）
3 mouths
Right heart dysfunction
Time Frame: 15 days
Duration of tracheal intubation（d)
15 days
Right heart dysfunction
Time Frame: 15 days
P-V Curve of curve
15 days
Right heart dysfunction
Time Frame: 15 days
TAPSE
15 days
Right heart dysfunction
Time Frame: 3 mouths
TAPSE
3 mouths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 27, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 27, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2024071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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