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Assessment of the prognostic significance of the leg positive pressure stress echocardiography for patients with aortic valve stenosis

Assessment of the prognostic significance of the leg positive pressure stress echocardiography for patients with aortic valve stenosis - Prognostic assessment using leg positive pressure stress echocardiography

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022391
Enrollment
70
Registered
2016-05-20
Start date
2016-08-17
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

Patients with aortic valve stenosis

Interventions

Sponsors

Division of cardiology, Kobe university hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients between 20 and 95 years old. 2 Out patients and inpatients with aortic valve stenosis. 3 Patients with hemodynamically stable condition with standard heart failure treatment including beta blocker, ACE inhibitor, ARB, and diuretics. 4 Patients who can tolerate 5 minutes of leg positive pressure stress echocardiography. 5 Patients with written informed consent. 6 patients whom judged to be able to survaive more than one year.

Exclusion criteria

Exclusion criteria: 1) Patients with significant hypotension (<90/50mmHg) or uncontrolled hypertension (>170/90mmHg). 2) Patients with acute illness within 3 months. 3) Patients with NYHA 4 heart failure. 4) Patients with unstable angina pectoris or more than 75% (AHA craiteria)coronary artery stenosis. 5) patients with more than moderate valvular regurgitation. 6) Patients with severe hepatic diseases including fulminant hepatitis, liver cirrhosis, or hepatic tumor. 7) Patients with severe renal diseased or those with hemodialysis. 8) Patients who experienced malignancy within 5 years. 9) Pregnant women. 10) Patients with venous thrombosis or the history of venous thrombosis. 11) Patients with leg trauma and dermopathy or the history of those diseases.

Design outcomes

Primary

MeasureTime frame
Combined endpoint of admission due to heart failure, death from heart failure, sudden cardiac death, and fatal ventricular arrhythmias.

Secondary

MeasureTime frame
1) Change in NYHA functional class from baseline. 2) Changes in left ventricular ejection fraction, left ventricular end-diastolic, and end-systolic volume from baseline. 3) changes in contractile reserve and diastorlic reserve from baseline. 4) Changes in right ventricular and left atrial function from baseline using speckle-tracking echocardiography.

Countries

Japan

Contacts

Public ContactKensuke Matsumoto

Kobe university hospital Division of cardiology

kenmatsu@med.kobe-u.ac.jp078-382-5846

Outcome results

None listed

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