Valvular Heart DiseaseJXVDNCT05523193
Valvular Heart Disease in Jiangxi Province
An observational study of Valvular Heart Disease and Treatment Adherence and Compliance, run by Xiao Huang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Disease, Treatment Adherence and Compliance
- What is being tested?
- Formal treatment model
- How many people
- 1,052 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Aug 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
About this study
Official title: A Real World Study of Valvular Heart Disease in Jiangxi Province
Study Title: A real-world study of valvular heart disease in Jiangxi Province
Research Objectives:
Read more
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.
Read the 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.
- Surgical procedures: valve repair or replacement, left auricular ligation, left auricular clip.
- 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.
- Being tested
- Formal treatment model
- Keywords
- Valvular Heart Disease, Valvular regurgitation, Valvular stenosis, TAVI
- Medical subject headings
- Heart Valve Diseases, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal treatment modelOther
Formal treatment model , no further surgery or minimally invasive treatment was performed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after surgery or treatment
Secondary outcomes (10)
All-cause mortality
Including cardiac death and non-cardiac death
Measured: surgery or 30 days after treatment
incidence of stroke
The incidence of stroke 30 days after discharge from hospital after surgery or treatment
Measured: 30 days after discharge from hospital after surgery or treatment
rate of permanent pacemaker implantation
The rate of permanent pacemaker implantation after surgery or 30 days after treatment
Measured: surgery or 30 days after treatment
Moderate or higher valvular regurgitation
Moderate or higher valvular regurgitation after surgery or 30 days after discharge
Measured: immediately after the surgery or 30 days after discharge
Readmission rates for aortic stenosis and/or valve implantation-related complications
Readmission rates for aortic stenosis and/or valve implantation-related complications at 30 days and 1 year after surgery or treatment
Measured: 30 days and 1 year after surgery or treatment
The incidence of intraoperative temporary valve size replacement
including increasing or decreasing valve size
Measured: intraoperative
The incidence of abnormal valve position
including valve displacement, valve embolism, and valve ectopic release
Measured: during operation
The incidence of implantation of two or more valves
The incidence of implantation of two or more valves during aortic valve replacement
Measured: during aortic valve replacement
The Barthel index
The Barthel index was used to evaluate the health status of the subjects
Measured: 30 days and 1 year after surgery or treatment
NYHA classification
NYHA classification at 30 days and 1 year after discharge after surgery or treatment
Measured: 30 days and 1 year after discharge after surgery or treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,052 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xiao Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Huang, Second Affiliated Hospital of Nanchang University
- Investigators
- Yanqing Wu, President, Principal investigator, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523193
- Sponsor's protocol ID
- 2022-07
- Acronym
- JXVD
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23547127Carita 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.
PubMed 27582763Dweck 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.
PubMed 23062541Sathyamurthy 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.
PubMed 26432749Soler-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.
PubMed 10814642
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Valvular Heart Disease in Jiangxi Province
- ClinicalTrials.gov ID
- NCT05523193
- Acronym / sponsor ID
- JXVD / 2022-07
- Keywords
- Valvular Heart Disease, Valvular regurgitation, Valvular stenosis, TAVI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,052 participants (estimated)
- Lead sponsor
- Xiao HuangUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Surgical procedures: valve repair or replacement, left auricular ligation, left auricular clip.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Other: Formal treatment modelTreatment 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formal treatment modelFormal treatment model , no further surgery or minimally invasive treatment was performed | Other | Treatment group |
Primary outcome
Primary endpoints
Time frame: 1 year after surgery or treatment
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
10 secondary outcomes
All-cause mortality
Time frame: surgery or 30 days after treatment
incidence of stroke
Time frame: 30 days after discharge from hospital after surgery or treatment
rate of permanent pacemaker implantation
Time frame: surgery or 30 days after treatment
Moderate or higher valvular regurgitation
Time frame: immediately after the surgery or 30 days after discharge
Readmission rates for aortic stenosis and/or valve implantation-related complications
Time frame: 30 days and 1 year after surgery or treatment
The incidence of intraoperative temporary valve size replacement
Time frame: intraoperative
The incidence of abnormal valve position
Time frame: during operation
The incidence of implantation of two or more valves
Time frame: during aortic valve replacement
The Barthel index
Time frame: 30 days and 1 year after surgery or treatment
NYHA classification
Time frame: 30 days and 1 year after discharge after surgery or treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Results publication: PubMed 23547127Cary 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.
- Results publication: PubMed 27582763Carita 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.
- Results publication: PubMed 23062541Dweck 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.
- Results publication: PubMed 26432749Sathyamurthy 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.
- Results publication: PubMed 10814642Soler-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Wu, President principal investigator
Second Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease and Treatment Adherence and Compliance, run by Xiao Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints (time frame: 1 year after surgery or treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523193, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.