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NCT06663566

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

ENROLLING BY INVITATION Last updated 29 October 2024
What this trial tests

trial testing Diagnose the patients right heart function as well as right heart fibrosis in Right Heart Insufficiency in 90 participants. Enrolling by invitation.

Timeline
15 August 2024
Primary endpoint
30 September 2027
30 December 2027

Quick facts

Lead sponsorBeijing Anzhen Hospital
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment90
Start date15 August 2024
Primary completion30 September 2027
Estimated completion30 December 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Beijing Anzhen Hospital

Who can join

Adults 18 to 90, any sex, with Right Heart Insufficiency or Tricuspid Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

\"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.\"

Publications & conference data

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