Clinical trial NCT05523193: Valvular Heart Disease in Jiangxi Province
Official title: A Real World Study of Valvular Heart Disease in Jiangxi Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Valvular Heart Disease
Treatment Adherence and Compliance
Keywords: Valvular Heart Disease
Valvular regurgitation
Valvular stenosis
TAVI
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 1052
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Summary of Research Protocol:

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.

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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary endpoints
timeFrame: 1 year after surgery or treatment
Secondary outcomes:
measure: All-cause mortality
timeFrame: surgery or 30 days after treatment
measure: incidence of stroke
timeFrame: 30 days after discharge from hospital after surgery or treatment
measure: rate of permanent pacemaker implantation
timeFrame: surgery or 30 days after treatment
measure: Moderate or higher valvular regurgitation
timeFrame: immediately after the surgery or 30 days after discharge
measure: Readmission rates for aortic stenosis and/or valve implantation-related complications
timeFrame: 30 days and 1 year after surgery or treatment
measure: The incidence of intraoperative temporary valve size replacement
timeFrame: intraoperative
measure: The incidence of abnormal valve position
timeFrame: during operation
measure: The incidence of implantation of two or more valves
timeFrame: during aortic valve replacement
measure: The Barthel index
timeFrame: 30 days and 1 year after surgery or treatment
measure: NYHA classification
timeFrame: 30 days and 1 year after discharge after surgery or treatment
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: Yanqing Wu, President
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.