A Multicentre Retrospective Study on Bicuspid Aortic Valve

Bicuspid Aortic Valve Clinical Trial

Official title:

Multicentre Retrospective Analysis of the Characteristics and the Long-term Prognosis of the Bicuspid Aortic Valve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818722
• Other study ID #: 2022-671
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Jing Yao, Phd
• Phone: +8618905188727
• Email: w1835199709[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners. Asian populations with BAV have different morphological characteristics from those of the Western populations, and further elucidation of these differences will serve as a guide for the treatment and follow-up of Asian patients. Therefore, we conducted this multicentre retrospective study to analysis the clinical features, long-term development and surgical prognosis of BAV .

Description:

Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners, and more than one half of patients require medical or surgical treatment within 20 years of diagnosis. Therefore, early diagnosis and effective treatment can help to reduce the incidence of irreversible cardiac impairment and adverse outcomes such as sudden death. Asian populations with BAV have morphological characteristics that differ from those of the Western populations, and further elucidation of these differences could serve as a guide for the treatment and follow-up of Chinese patients. Based on the above background, We conducted this multicentre retrospective study. We will search for patients diagnosed with BAV by echocardiography or other imaging examinations from December 2021 to October 2022 at Nanjing Gulou Hospital, Jiangsu Provincial Hospital and Nanjing Children's Hospital; collect clinical symptoms, signs and examination results of them; find out the specific surgical plan and time of surgery if they have undergone surgery; follow up for symptoms, medication and reexamin Echocardiography to confirm any endpoint events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with a suspected diagnosis of Bicuspid Aortic Valve by echocardiogram from December 2021 to October 2022

Exclusion Criteria:

• Patients with suspected Bicuspid Aortic Valve not clearly diagnosed by echocardiography and not confirmed by cardiac surgery

Related Conditions & MeSH terms

• Bicuspid Aortic Valve
• Bicuspid Aortic Valve Disease
• Heart Valve Diseases

Locations

Country	Name	City	State
China	Affiliated Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing Children's Hospital, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Fedak PWM. Bicuspid aortic valve and the specialty clinic: are your patients at risk? Cardiol Young. 2017 Apr;27(3):411-412. doi: 10.1017/S1047951117000282. Epub 2017 Mar 6. No abstract available. — View Citation

Fernandes JF, Gill H, Nio A, Faraci A, Galli V, Marlevi D, Bissell M, Ha H, Rajani R, Mortier P, Myerson SG, Dyverfeldt P, Ebbers T, Nordsletten DA, Lamata P. Non-invasive cardiovascular magnetic resonance assessment of pressure recovery distance after aortic valve stenosis. J Cardiovasc Magn Reson. 2023 Jan 30;25(1):5. doi: 10.1186/s12968-023-00914-3. — View Citation

Lee M, Sung J, Cho SJ, Choi SH, Cho SW, Oh JK, Park SJ, Kim DK. Aortic dilatation and calcification in asymptomatic patients with bicuspid aortic valve: analysis in a Korean health screening population. Int J Cardiovasc Imaging. 2013 Mar;29(3):553-60. doi: 10.1007/s10554-012-0116-3. Epub 2012 Aug 26. — View Citation

Lo Presti F, Guzzardi DG, Bancone C, Fedak PWM, Della Corte A. The science of BAV aortopathy. Prog Cardiovasc Dis. 2020 Jul-Aug;63(4):465-474. doi: 10.1016/j.pcad.2020.06.009. Epub 2020 Jun 26. — View Citation

Movahed MR, Hepner AD, Ahmadi-Kashani M. Echocardiographic prevalence of bicuspid aortic valve in the population. Heart Lung Circ. 2006 Oct;15(5):297-9. doi: 10.1016/j.hlc.2006.06.001. Epub 2006 Aug 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death	Death from any causes	1 year
Primary	Cardical mortality	Death due to cardiac disease including MI, arrhythmia, heart failure and aortic lesions	1 year