Hypertension, PulmonaryPhase 2/3SUPERIORNCT02435303
Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)
A Phase 2/3 study testing Sildenafil in people with Hypertension, Pulmonary and Diseases of Mitral Valve, run by Asan Medical Center.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Pulmonary, Diseases of Mitral Valve
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Hypertension, Pulmonary, Diseases of Mitral Valve
- Being tested
- Sildenafil, Placebo
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Viagra, Revatio, others
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Sildenafil 20mg tid for six months (* consider open-label extension study for 1 year) Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Six Minutes Walk Distance
unit of measure : meter (m)
Measured: baseline and six months
Secondary outcomes (6)
Borg dyspnea score
Measured: six months
Exercise capacity by cardiopulmonary exercise test
Measured: six months
Fractional area change of right ventricle measured by echocardiography
unit of measure : percent (%)
Measured: six months
Pulmonary vascular resistance (PVR) measured by cardiac catheterization
unit of measure : wood unit (WU)
Measured: six months
Systolic pulmonary artery pressure measured by cardiac catheterization
unit of measure : pressure (mmHg)
Measured: six months
Mean pulmonary artery pressure measured by cardiac catheterization
unit of measure : pressure (mmHg)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2016
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: Number of candidates for this study is expected to be too small.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Min Song, Asan Medical Center
- Investigators
- Jong-Min Song, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435303
- Sponsor's protocol ID
- MVsurgery_PAH
- Acronym
- SUPERIOR
- Status last verified
- Jul 2019
- First submitted
- 28 Apr 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease
- ClinicalTrials.gov ID
- NCT02435303
- Acronym / sponsor ID
- SUPERIOR / MVsurgery_PAH
- Conditions
- Hypertension, Pulmonary, Diseases of Mitral Valve
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of candidates for this study is expected to be too small.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: SildenafilSildenafil 20mg tid for six months (* consider open-label extension study for 1 year) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: Viagra, Revatio, others | Drug | Sildenafil |
| Placebo | Drug | Placebo |
Primary outcome
Change of Six Minutes Walk Distance
Time frame: baseline and six months
unit of measure : meter (m)
6 secondary outcomes
Borg dyspnea score
Time frame: six months
Exercise capacity by cardiopulmonary exercise test
Time frame: six months
Fractional area change of right ventricle measured by echocardiography
Time frame: six months
Pulmonary vascular resistance (PVR) measured by cardiac catheterization
Time frame: six months
Systolic pulmonary artery pressure measured by cardiac catheterization
Time frame: six months
Mean pulmonary artery pressure measured by cardiac catheterization
Time frame: six months
Results and safety
The study was stopped early (reason given: Number of candidates for this study is expected to be too small.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Min Song principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sildenafil in people with Hypertension, Pulmonary and Diseases of Mitral Valve, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Number of candidates for this study is expected to be too small.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Six Minutes Walk Distance (time frame: baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.