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Association between the trajectory of Ventricular Arterial Coupling and clinical outcomes in patients with severe Aortic Stenosis

Association between the trajectory of Ventricular Arterial Coupling and clinical outcomes in patients with severe Aortic Stenosis - VACAS study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000041924
Enrollment
710
Registered
2020-09-30
Start date
2020-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Interventions

None listed

Sponsors

Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Retrospective study (1) Those who are 20 years of age or older at the time of obtaining consent (2) Patients with severe aortic valve stenosis diagnosed by echocardiography (maximum velocity of blood flow through the aortic valve >=4.0 m/s by continuous wave Doppler, mean pressure gradient >=40 mmHg by simple Bernoulli formula, valve mouth area <=1.0 cm2, or valve mouth area coefficient <=0.6 cm2/m2 are met). (3) A person who, after receiving a full explanation from the researcher, has obtained the subject's voluntary consent to participate in the study with a full understanding Prospective study Sergical treatment group (1) Those who are 20 years of age or older at the time of obtaining consent (2) Patients with severe aortic valve stenosis diagnosed by echocardiography (maximum velocity of blood flow through the aortic valve >=4.0 m/s by continuous wave Doppler, mean pressure gradient >=40 mmHg by simple Bernoulli formula, valve mouth area <=1.0 cm2, or valve mouth area coefficient <=0.6 cm2/m2 are met). (3) Those who plan to have a radical cure within 3 months of registration. (4) A person who, after receiving a full explanation from the researcher, has obtained the subject's voluntary consent to participate in this research with sufficient understanding. Conservative treatment group (1) Those who are 20 years of age or older at the time of obtaining consent (2) Patients with severe aortic valve stenosis diagnosed by echocardiography (maximum velocity of blood flow through the aortic valve >=4.0 m/s by continuous wave Doppler, mean pressure gradient >=40 mmHg by simple Bernoulli formula, valve mouth area <=1.0 cm2, or valve mouth area coefficient <=0.6 cm2/m2 are met). (3) Those who have not scheduled a radical cure within three months of registration (4) A person who, after receiving a full explanation from the researcher, has obtained the subject's voluntary consent to participate in this research with sufficient understanding.

Exclusion criteria

Exclusion criteria: Retrospective study (1) A person who has offered to refuse to cooperate in the research after disclosing information using the opt-out method (2) Other persons who are deemed by the principal investigator to be unsuitable as research subjects Prospective study (1) Other persons who are deemed by the principal investigator to be unsuitable as research subjects

Design outcomes

Primary

MeasureTime frame
First occurrence of death, development or progression of heart failure, or hospitalization for heart failure by the end of the study

Secondary

MeasureTime frame
(1) Individual incidences of death, development or exacerbation of heart failure, and heart failure hospitalization during the study period (2) The occurrence of primary outcomes at 6, 12 and 24 months. (3) Changes in ventricular artery coupling over time (4) Comparison with existing prognostic indicators

Countries

Japan

Contacts

Public ContactYoshifumi Mizuguchi

Faculty of Medicine and Graduate School of Medicine, Hokkaido University Department of Cardiovascular Medicine

mizu-tay@med.hokudai.ac.jp011-706-6973

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026