Valvular Heart Disease in Jiangxi Province

NCT05523193 | Unknown DMC

• 1 other identifier: 2022-07
• Study Type: observational
• Target: 1,052
• Locations: 1 country
• Sites: 1

Brief Summary

Study Title: A real-world study of valvular heart disease in Jiangxi Province Research Objectives: ① Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients. ② Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period. Design type: a prospective, observational, real-world study (at least 1.5 years). No pre-established fixed treatment protocols, only a Formal treatment model,with all treatment choices made entirely by clinicians following relevant textbooks, expert consensus on clinical guidelines, and based on the patient's condition. Subjects: All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.

Conditions

Valvular Heart Disease; Treatment Adherence and Compliance

Keywords

Valvular Heart Disease; Valvular regurgitation; Valvular stenosis; TAVI

Outcome Measures

Primary Outcomes (1)

• Primary endpoints

  all-cause mortality, disabling stroke, and incidence of cardiogenic stroke, permanent pacemaker implantation rate, and moderate or greater valve regurgitation at 1 year after surgery or discharge from treatment

  1 year after surgery or treatment

Secondary Outcomes (10)

• All-cause mortality

  surgery or 30 days after treatment

• incidence of stroke

  30 days after discharge from hospital after surgery or treatment

• rate of permanent pacemaker implantation

  surgery or 30 days after treatment

• Moderate or higher valvular regurgitation

  immediately after the surgery or 30 days after discharge

• Readmission rates for aortic stenosis and/or valve implantation-related complications

  30 days and 1 year after surgery or treatment

Study Arms (2)

Treatment group

Treatment group (Formal treatment model group): Patients who agree and accept the surgical treatment recommendation (including medical and surgical treatment) enter the formal treatment model group. Those who have received any of the following treatments (including but not limited to) as recommended by the standardized treatment process are considered to have received the standardized treatment, otherwise, they have not. 1. Surgical procedures: valve repair or replacement, left auricular ligation, left auricular clip. 2. Internal surgery: transcatheter valve replacement, radiofrequency ablation of atrial fibrillation, and left heart ear occlusion.

Other: Formal treatment model

Control group

Control group（Conventional treatment model group）:Patients who do not agree to enter the Formal treatment model group will automatically enter the Conventional treatment model group.

Interventions

Formal treatment model OTHER

Formal treatment model , no further surgery or minimally invasive treatment was performed

Treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.

You may qualify if:

• All moderate-to-severe heart valve disease, including aortic, mitral, and tricuspid valves;
• Comply with the ESC/EACTS Guidelines for the Management of Valvular Heart Disease (2021) indications for surgery for valvular heart disease;
• Understand and voluntarily sign the informed consent form

You may not qualify if:

• those with severe mental disorders and unable to express their will;
• those with obvious other abnormal signs, laboratory tests and clinical diseases that, in the judgment of the investigator, make them unsuitable for participation in the study;
• those who, in the judgment of the investigator, are unable to complete long-term follow-up.

Sponsors & Collaborators

• Xiao Huang: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

Related Publications (5)

• Cary T, Pearce J. Aortic stenosis: pathophysiology, diagnosis, and medical management of nonsurgical patients. Crit Care Nurse. 2013 Apr;33(2):58-72. doi: 10.4037/ccn2013820.

  PMID: 23547127 RESULT

• Carita P, Coppola G, Novo G, Caccamo G, Guglielmo M, Balasus F, Novo S, Castrovinci S, Moscarelli M, Fattouch K, Corrado E. Aortic stenosis: insights on pathogenesis and clinical implications. J Geriatr Cardiol. 2016 Sep;13(6):489-98. doi: 10.11909/j.issn.1671-5411.2016.06.001.

  PMID: 27582763 RESULT

• Dweck MR, Boon NA, Newby DE. Calcific aortic stenosis: a disease of the valve and the myocardium. J Am Coll Cardiol. 2012 Nov 6;60(19):1854-63. doi: 10.1016/j.jacc.2012.02.093. Epub 2012 Oct 10.

  PMID: 23062541 RESULT

• Sathyamurthy I, Alex S. Calcific aortic valve disease: is it another face of atherosclerosis? Indian Heart J. 2015 Sep-Oct;67(5):503-6. doi: 10.1016/j.ihj.2015.07.033. Epub 2015 Aug 21.

  PMID: 26432749 RESULT

• Soler-Soler J, Galve E. Worldwide perspective of valve disease. Heart. 2000 Jun;83(6):721-5. doi: 10.1136/heart.83.6.721. No abstract available.

  PMID: 10814642 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect blood samples, tissues and body fluids according to the requirements of the sample bank

MeSH Terms

Conditions

Heart Valve Diseases; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Study Officials

• Yanqing Wu, President

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

CN (1)