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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension, Pulmonary; Diseases of Mitral Valve
• Intervention / Treatment: Drug: Placebo; Drug: Sildenafil

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sildenafil; Sildenafil 20mg tid for six months (* consider open-label extension study for 1 year)	Drug: Sildenafil; Other Names: Viagra, Revatio, others
Placebo Comparator: Placebo; Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Six Minutes Walk Distance	unit of measure : meter (m)	baseline and six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borg dyspnea score		six months
Exercise capacity by cardiopulmonary exercise test		six months
Fractional area change of right ventricle measured by echocardiography	unit of measure : percent (%)	six months
Pulmonary vascular resistance (PVR) measured by cardiac catheterization	unit of measure : wood unit (WU)	six months
Systolic pulmonary artery pressure measured by cardiac catheterization	unit of measure : pressure (mmHg)	six months
Mean pulmonary artery pressure measured by cardiac catheterization	unit of measure : pressure (mmHg)	six months

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Jong-Min Song, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: May 1, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: MVsurgery_PAH