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Enrolling by Invitation

NCT Number: NCT06663566

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

"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."

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Key information

Conditions

Right Heart Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Regurgitation Tricuspid Valve Insufficiency

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

FAPI

Beijing, Beijing Municipality, 100020, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Diagnose the patients right heart function as well as right heart fibrosis

Other

Diagnose the patients right heart function as well as right heart fibrosis

Diagnose the patient's right heart function as well as right heart fibrosis

Diagnostic Test

Diagnose the patient's right heart function as well as right heart fibrosis

Primary outcomes

  1. Right heart dysfunction

    Time frame: 15 days

    Central venous pressure（cmH2O）

  2. Right heart dysfunction

    Time frame: 3 mouths

    P-V Curve of curve（cmH2O）

  3. Right heart dysfunction

    Time frame: 15 days

    Duration of tracheal intubation（d)

  4. Right heart dysfunction

    Time frame: 15 days

    P-V Curve of curve

  5. Right heart dysfunction

    Time frame: 15 days

    TAPSE

  6. Right heart dysfunction

    Time frame: 3 mouths

    TAPSE

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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