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

NCT ID: NCT06663566

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2027-12-30

Brief Summary

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\"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.\"

Detailed Description

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Conditions

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Right Heart Insufficiency Tricuspid Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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high-FAPI+

FAPI Nuclear Medicine Cardiac Imaging stronge Positive" in English.

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

Intervention Type DIAGNOSTIC_TEST

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

low-FAPI+

FAPI Nuclear Medicine Cardiac Imaging Weak Positive" in English.

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

Intervention Type DIAGNOSTIC_TEST

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

No FAPI+

FAPI nuclear medicine cardiac imaging negative

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaozheng Zhou

Doctor, Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Vessel Disease, Beijing 100029, China

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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FAPI

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Ye Y, Desai R, Vargas Abello LM, Rajeswaran J, Klein AL, Blackstone EH, Pettersson GB. Effects of right ventricular morphology and function on outcomes of patients with degenerative mitral valve disease. J Thorac Cardiovasc Surg. 2014 Nov;148(5):2012-2020.e8. doi: 10.1016/j.jtcvs.2014.02.082. Epub 2014 Mar 1.

Reference Type RESULT
PMID: 24698557 (View on PubMed)

Le Tourneau T, Deswarte G, Lamblin N, Foucher-Hossein C, Fayad G, Richardson M, Polge AS, Vannesson C, Topilsky Y, Juthier F, Trochu JN, Enriquez-Sarano M, Bauters C. Right ventricular systolic function in organic mitral regurgitation: impact of biventricular impairment. Circulation. 2013 Apr 16;127(15):1597-608. doi: 10.1161/CIRCULATIONAHA.112.000999. Epub 2013 Mar 13.

Reference Type RESULT
PMID: 23487435 (View on PubMed)

Towheed A, Sabbagh E, Gupta R, Assiri S, Chowdhury MA, Moukarbel GV, Khuder SA, Schwann TA, Bonnell MR, Cooper CJ, Khouri S. Right Ventricular Dysfunction and Short-Term Outcomes Following Left-Sided Valvular Surgery: An Echocardiographic Study. J Am Heart Assoc. 2021 Feb 16;10(4):e016283. doi: 10.1161/JAHA.120.016283. Epub 2021 Feb 9.

Reference Type RESULT
PMID: 33559474 (View on PubMed)

Purmah Y, Lei LY, Dykstra S, Mikami Y, Cornhill A, Satriano A, Flewitt J, Rivest S, Sandonato R, Seib M, Lydell CP, Howarth AG, Heydari B, Merchant N, Bristow M, Fine N, Gaztanaga J, White JA. Right Ventricular Ejection Fraction for the Prediction of Major Adverse Cardiovascular and Heart Failure-Related Events: A Cardiac MRI Based Study of 7131 Patients With Known or Suspected Cardiovascular Disease. Circ Cardiovasc Imaging. 2021 Mar;14(3):e011337. doi: 10.1161/CIRCIMAGING.120.011337. Epub 2021 Mar 16.

Reference Type RESULT
PMID: 33722059 (View on PubMed)

Kresoja KP, Rommel KP, Lucke C, Unterhuber M, Besler C, von Roeder M, Schober AR, Noack T, Gutberlet M, Thiele H, Lurz P. Right Ventricular Contraction Patterns in Patients Undergoing Transcatheter Tricuspid Valve Repair for Severe Tricuspid Regurgitation. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1551-1561. doi: 10.1016/j.jcin.2021.05.005.

Reference Type RESULT
PMID: 34294396 (View on PubMed)

Other Identifiers

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KS2024071

Identifier Type: -

Identifier Source: org_study_id

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