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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435303
Recruitment Status : Terminated (Number of candidates for this study is expected to be too small.)
First Posted : May 6, 2015
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jong-Min Song, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Diseases of Mitral Valve Drug: Sildenafil Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease
Study Start Date : May 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: Sildenafil
Sildenafil 20mg tid for six months (* consider open-label extension study for 1 year)
Drug: Sildenafil
Other Name: 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



Primary Outcome Measures :
  1. Change of Six Minutes Walk Distance [ Time Frame: baseline and six months ]
    unit of measure : meter (m)


Secondary Outcome Measures :
  1. Borg dyspnea score [ Time Frame: six months ]
  2. Exercise capacity by cardiopulmonary exercise test [ Time Frame: six months ]
  3. Fractional area change of right ventricle measured by echocardiography [ Time Frame: six months ]
    unit of measure : percent (%)

  4. Pulmonary vascular resistance (PVR) measured by cardiac catheterization [ Time Frame: six months ]
    unit of measure : wood unit (WU)

  5. Systolic pulmonary artery pressure measured by cardiac catheterization [ Time Frame: six months ]
    unit of measure : pressure (mmHg)

  6. Mean pulmonary artery pressure measured by cardiac catheterization [ Time Frame: six months ]
    unit of measure : pressure (mmHg)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435303


Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Jong-Min Song Asan Medical Center
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Responsible Party: Jong-Min Song, Professor, University of Ulsan College of Medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02435303    
Other Study ID Numbers: MVsurgery_PAH
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents