Non-rheumatic aortic valve stenosis
Conditions
Interventions
Intervention Group:Oral Shexiang Tongxin Dropping Pills+Standard treatment
Control Group:Oral Placebo+Standard treatment
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Age >=18 years; 2: Diagnosed with moderate or severe aortic stenosis by standard echocardiography (valve area =3.0 m/s, or mean pressure gradient >=36 mmHg); 3: Patients refuse or are not candidates for surgical intervention and transcatheter aortic valve replacement (TAVR); 4: Able to understand and sign the informed consent form, and willing to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1.Combined other moderate-to-severe valvular heart diseases (aortic regurgitation, mitral stenosis/regurgitation, tricuspid stenosis/regurgitation); 2.Rheumatic aortic valve disease; 3.Left ventricular ejection fraction <=40% by echocardiography or regional wall motion abnormalities indicative of prior significant myocardial infarction; 4.Received Shexiang Tongxin Dropping Pills or similar medications within the past 3 months; 5.History of allergy to any component of Shexiang Tongxin Dropping Pills; 6.Abnormal liver or kidney function; 7.Contraindications to cardiac magnetic resonance imaging (e.g., pacemaker, intracranial aneurysm clips, intraocular metallic foreign bodies, severe claustrophobia); 8.History of alcohol abuse or drug dependence; 9.Psychiatric disorders such as depression or anxiety disorder; 10.Severe neurological disorders, psychiatric illnesses, or cognitive impairment affecting self-assessment of symptoms or treatment compliance; 11.Patients with malignant tumors; 12.Women planning pregnancy, currently pregnant, or breastfeeding; 13.Participation in other interventional drug or medical device studies within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricular Mass Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mid-wall Late Gadolinium Enhancement;Left Ventricular Function Parameters;Aortic Valve Function;Functional Scale Grades and Scores;Major Adverse Cardiovascular Events;6-Minute Walk Test;Myocardial Strain;Plasma brain natriuretic peptides;C-reactive Protein; | — |
Countries
China
Contacts
Public ContactZhou Hao
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed