Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

NCT07267117 | Recruiting

• 1 other identifier: 2025-0528
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 15

Brief 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.

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

Keywords

Heart Valve Disease Progression; Heart Valve disease sequelae

Outcome Measures

Primary Outcomes (4)

• All cause mortality

  1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

• Heart valve replacement or repair

  Surgical Heart Valve Replacement/Repair or Transcatheter Aortic Valve Replacement/Repair

  1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

• Stroke

  Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.

  1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

• Re-hospitalization related to cardiovascular disease

  Requires rehospitalization due to cardiovascular diseases such as coronary atherosclerotic heart disease, heart failure, arrhythmia, pulmonary embolism, aortic disease, and hypertension.

  1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

Secondary Outcomes (4)

• Progression of valve stenosis or regurgitation

  1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

• Ventricular remodeling and deterioration of cardiac function

  1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

• Changes in quality of life and symptoms

  1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

• Newly Emerging Cardiovascular Disease and Complications

  1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Army Medical Center of PLA: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Xiangya Hospital of Central South University: collaborator
• The General Hospital of Northern Theater Command: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Huaxi Hospital: collaborator
• Fuwai Yunnan Cardiovascular Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Fujian Provincial Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Renmin Hospital of Wuhan University: collaborator
• The First Affiliated Hospital of Air Force Medicial University: collaborator
• Navy General Hospital, Beijing: collaborator

Study Sites (15)

Fujian Provincial Hospital, Affiliated to Fuzhou University

Fuzhou, Fujian, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

The General Hospital of Northern Theater Command

Shenyang, Liaoning, 110031, China

RECRUITING

The First Affiliated Hospital of Air Force Medicial University

Xi'an, Shaanxi, 710032, China

RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

Huaxi Hospital

Chengdu, Sichuan, China

RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830000, China

RECRUITING

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, 650032, China

RECRUITING

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, China

RECRUITING

Navy General Hospital, Beijing

Beijing, China

RECRUITING

Army Medical Center of PLA

Chongqing, 400010, China

RECRUITING

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200080, China

RECRUITING

Related Publications (1)

• 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 International Consortium for Health Outcomes Measurement (ICHOM) Standard Dataset for Reporting Outcomes in Heart Valve Disease: Moving From Device- to Patient-Centered Outcomes: Developed by a multisociety taskforce coordinated by the Heart Valve Society (HVS) including the American Heart Association (AHA), the American College of Cardiology (ACC), the European Association for Cardio-Thoracic Surgery (EACTS), the European Society of Cardiology (ESC), The Society of Thoracic Surgeons (STS), the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS), the International Society for Applied Cardiovascular Biology (ISACB), the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), the South African Heart Association (SHA), Heart Valve Voice, and Global Heart Hub. JACC Adv. 2025 Apr;4(4):101059. doi: 10.1016/j.jacadv.2024.101059. Epub 2025 Feb 17.

  PMID: 39966045 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The patient's blood sample is kept in a suitable way, centrifuged and aliquoted, etc., and stored in a -80° freezer。

MeSH Terms

Conditions

Heart Valve Diseases; Gastroesophageal Reflux; Mitral Valve Stenosis; Aortic Valve Disease; Aortic Valve Stenosis; Tricuspid Valve Insufficiency; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2030
• Last Updated: December 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)