NCT07267117

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.

Detailed description

This study is a prospective observational cohort study designed to investigate the disease progression, medication and surgical intervention patterns, outcomes, and influencing factors in patients with moderate or greater cardiac valve stenosis and Grade II or higher cardiac valve regurgitation. The study population includes patients diagnosed at 15 major medical institutions in China, including the Second Affiliated Hospital of Zhejiang University School of Medicine and West China Hospital of Sichuan University. The severity of valvular heart disease is determined according to a standardized dataset (JACC Adv. 2025 Apr) developed by a joint task force comprising multiple international societies. Currently, there is a lack of clear consensus regarding the management of patients with moderate valvular stenosis and regurgitation, and their subsequent disease progression remains poorly understood. Notably, the time span for progression from moderate to severe valvular heart disease can vary from 1 to 10 years, and monitoring and early warning mechanisms for potential early markers indicating disease deterioration are currently underdeveloped. Furthermore, patients with severe valvular heart disease may experience different outcomes following various device implantations, and the associated risk factors require further clarification. The objective of this study is to identify all clinical, biological, echocardiographic, and imaging parameters that may increase the risk of disease progression or adverse outcomes through a prospective observational cohort design. The confirmation of these parameters will guide future research in developing pharmacological and interventional treatment strategies to reduce mortality associated with this disease. Patients enrolled in this study will undergo annual outpatient follow-up visits after diagnosis, which will include electrocardiography, echocardiography, blood analysis, and contrast-enhanced CT scans. Through these comprehensive monitoring methods, we aim to accurately assess changes in patients' conditions and provide a scientific basis for clinical decision-making.

Conditions

• Heart Valve Disease
• Mitral Valve (MV) Regurgitation
• Mitral Valve Disease
• Mitral Valve Stenosis
• Aortic Valve Disease
• Aortic Valve Stenosis
• Tricuspid Valve Disease
• Tricuspid Valve Regurgitation
• Aortic Valve Regurgitation
• Pulmonary Valve Disease
• Transcatheter Valve Replacement
• Transcatheter Aortic Valve Replacement (TAVR)
• Transcatheter Pulmonary Valve Replacement (TPVR)
• Transcatheter Edge-to-edge Repair

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-12-31
• Completion: 2030-05-31
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

15 sites across 1 country: China