Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)

Hypertension, Pulmonary Clinical Trial

— SUPERIOR  

Official title:

Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02435303
• Other study ID #: MVsurgery_PAH
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: May 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Sildenafil is effective in the treatment of sustained pulmonary artery hypertension after corrected mitral valve disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• New York Heart Association Functional class (NYHA Fc) = 2 dyspnea which was sustained till one year after the previous mitral valve surgery (repair or replacement)

• TR Vmax = 3.5m/s by echocardiography

• Normal left ventricle ejection fraction (EF = 50%)

• Pulmonary vascular resistance = 3 Wood Unit or diastolic pressure gradient = 7mmHg by cardiac catheterization

Exclusion Criteria:

• Other valve disease more than moderate degree (ex. aortic stenosis, aortic regurgitation)

• Liver cirrhosis

• Chronic renal failure with serum creatinine = 1.7mg/dL

• Lung disease (ex. chronic obstructive pulmonary disease, Asthma)

• Thyroid dysfunction

• Other causes which can lead to pulmonary hypertension

Related Conditions & MeSH terms

• Diseases of Mitral Valve
• Heart Valve Diseases
• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Sildenafil

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Six Minutes Walk Distance	unit of measure : meter (m)	baseline and six months
Secondary	Borg dyspnea score		six months
Secondary	Exercise capacity by cardiopulmonary exercise test		six months
Secondary	Fractional area change of right ventricle measured by echocardiography	unit of measure : percent (%)	six months
Secondary	Pulmonary vascular resistance (PVR) measured by cardiac catheterization	unit of measure : wood unit (WU)	six months
Secondary	Systolic pulmonary artery pressure measured by cardiac catheterization	unit of measure : pressure (mmHg)	six months
Secondary	Mean pulmonary artery pressure measured by cardiac catheterization	unit of measure : pressure (mmHg)	six months