Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

Official title

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

Overview

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.

Primary outcome measures

• All cause mortality [Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up]
• Heart valve replacement or repair [Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up]
• Stroke [Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up]
• Re-hospitalization related to cardiovascular disease [Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up]

Secondary outcome measures (4)

• Progression of valve stenosis or regurgitation [Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up]
• Ventricular remodeling and deterioration of cardiac function [Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up]
• Changes in quality of life and symptoms [Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up]
• Newly Emerging Cardiovascular Disease and Complications [Time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up]

Eligibility criteria

Inclusion criteria

• At least 18 years old;
• Be willing and able to provide informed consent to participate in the study;
• Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria:

• Grade II or higher Aortic valve regurgitation: regurgitant jet width >3 mm, jet width / LVOT diameter ≥25%, jet cross-sectional area/LVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%.
• Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m/s, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²/m², or velocity ratio ≤0.50.
• Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area/left atrial area >30%, or effective regurgitant orifice area (EROA) ≥0.2 cm².
• Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.
• Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml.
• Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral >60 cm, T1/2 ≥190 ms, or valve area ≤1.0 cm².
• Grade II or higher pulmonary valve regurgitation: regurgitant jet width >3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm².
• Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening <1.5 cm².

Exclusion criteria

• Patients who are unwilling to accept registration and follow-up;
• Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions;
• Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 15 centers

• Fujian Provincial Hospital, Affiliated to Fuzhou University — Fuzhou
• Renmin Hospital of Wuhan University — Wuhan
• Xiangya Hospital of Central South University — Changsha
• Second Xiangya Hospital of Central South University — Changsha
• The General Hospital of Northern Theater Command — Shenyang
• The First Affiliated Hospital of Air Force Medicial University — Xi'an
• Affiliated Hospital of Qingdao University — Qingdao
• Huaxi Hospital — Chengdu
• … and 7 more centers

Publications

• Lansac E, Veen KM, Joseph A, Blancarte Jaber P, Sossi F, Das-Gupta Z, Aktaa S, Sadaba JR, Thourani VH, Dahle G, Szeto WY, Bakaeen F, Aikawa E, Schoen FJ, Girdauskas E, Almeida A, Zuckermann A, Meuris B, Stott J, Kluin J, Meel R, Woan W, Colgan D, Jneid H, Balkhy H, Szerlip M, Preventza O, Shah P, Rigolin VH, Medica S, Holmes P, Sitges M, Pibarot P, Donal E, Hahn RT, Takkenberg JJM. The First Inter PMID 39966045

Identifiers

NCT: NCT07267117 · 2025-0528

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗