Pulmonary HypertensionPhase 2NCT00145938
Sildenafil and Pulmonary Artery Pressure
A Phase 2 study testing sildenafil in people with Pulmonary Hypertension, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of the study is to see if the administration of sildenafil (Viagra) in patients with portopulmonary hypertension could be a safe and effective treatment. Portopulmonary hypertension (PTPH) is a special type of pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- sildenafil
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Sep 2006
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for enrollment in this clinical trial are limited to adult patients diagnosed with severe portopulmonary hypertension (PTPH). Specifically, other causes of pulmonary hypertension (PH) such as left ventricular dysfunction, valvular heart disease, chronic lung disease, chronic thromboembolic disease, chronic hypoxemia, rheumatologic conditions, and significant untreated obstructive sleep apnea will be excluded in the usual fashion in patients with underlying portal hypertension and usually cirrhosis. The diagnosis of pulmonary hypertension will be confirmed by invasive hemodynamic measurements (i.e. right heart catheterization) and severe PH is defined as a mean pulmonary artery pressure (MPAP) >35 mmHg. If evidence of right ventricular (RV) dysfunction is present (RV dilation, reduced RV ejection fraction (EF), or elevated RV end-diastolic pressure (>10 mmHg) and the MPAP is 30-35 mmHg, then the patient may be enrolled.
- Study participants will be selected from those patients referred for hemodynamic assessment of pulmonary hypertension, such as potential liver transplant recipients. They must be capable of giving informed consent. The University of Chicago referring physician will be contacted for concurrence of agreement.
Who cannot join
- Patients with pulmonary arterial hypertension, but not portopulmonary hypertension will be excluded. Patients will be excluded from consideration if they do not have severe PTPH, if invasive hemodynamic assessment is contraindicated, or if there are any contraindications to sildenafil. Patients with unstable coronary syndromes or otherwise significant unrevascularized coronary artery disease and myocardial ischemia as determined by cardiac stress testing and/or coronary angiography will also be excluded. Moribund patients will not be considered for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Effect of Chronic Administration of Sildenafil on Pulmonary Artery Pressure in Patients With Portopulmonary Hypertension
The purpose of the study is to see if the administration of sildenafil (Viagra) in patients with portopulmonary hypertension could be a safe and effective treatment.
Portopulmonary hypertension (PTPH) is a special type of pulmonary hypertension. Pulmonary hypertension is high blood pressure in the pulmonary arteries that carry unoxygenated blood from the right ventricle of the heart to the lungs. Pulmonary hypertension results from constriction, or tightening, of the blood vessels that supply blood to the lungs. Consequently, it becomes difficult for blood to pass through the lungs, making it harder for the heart to pump blood forward. This stress on the heart leads to enlargement of the heart and eventually fluid can build up in the liver and tissues, such as in the legs. Affected patients can sometimes notice increasing shortness of breath and dizziness.
Read more
There is a growing body of evidence suggesting a potential therapeutic role for this sildenafil in patients with primary pulmonary hypertension. Studies are ongoing regarding this area.
Our hypothesis is that chronic oral sildenafil will successfully reduce pulmonary artery pressures by at least 25% (reduction in mean pulmonary artery pressure) and could be an effective treatment for PTPH, especially in candidates for liver transplantation
Primary Hypothesis To measure the effects of a single dose of sildenafil on pulmonary arterial pressure in patients with PTPH
Secondary Hypothesis To measure the effects of chronic (3 month) treatment with sildenafil on pulmonary arterial pressure, safety, and tolerability in patients with PTPH
Read the detailed description
This is a single center (only takes place at University of Chicago), open-label (doctor and subject know that the subject is taking the experimental drut), pilot study to evaluate the effects of sildenafil on pulmonary artery pressures in patients with portopulmonary hypertension.
Patients who are diagnosed with PTPH after having routine care right heart catheterization will be asked if they are interested in participating. Approximately ten subjects will be enrolled. Subjects will undergo the following experimental procedures as part of their participation in this study: blood laboratory tests, medical history, physical exam, inhaled nitric oxide test, study drug (sildenafil) administration, and a pill count.
Sildenafil will be given to these patients 3 times a day for a 12 week period to see if the study drug can lower their pulmonary artery pressures by at least 25%.
- Conditions
- Pulmonary Hypertension
- Being tested
- sildenafil
- Keywords
- Portopulmonary hypertension, PTPH, pulmonary hypertension, high blood pressure in the pulmonary arteries
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measurement will consist of comparing baseline to treatment hemodynamics both after a single dose and chronic therapy in terms of absolute response as well as the presence of a "significant response" defined as at least a 25% reduction in mean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionSep 2006
- Study completionSep 2006
Why it stopped: Unable to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allen Anderson, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145938
- Sponsor's protocol ID
- 12562A
- Status last verified
- Sep 2006
- First submitted
- 1 Sep 2005
- Last updated
- 8 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Chronic Administration of Sildenafil on Pulmonary Artery Pressure in Patients With Portopulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00145938
- Acronym / sponsor ID
- 12562A
- Conditions
- Pulmonary Hypertension
- Keywords
- Portopulmonary hypertension, PTPH, pulmonary hypertension, high blood pressure in the pulmonary arteries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete study
- Enrolment
- 10 participants
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 5 Sep 2005 (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 the study is to see if the administration of sildenafil (Viagra) in patients with portopulmonary hypertension could be a safe and effective treatment.
Portopulmonary hypertension (PTPH) is a special type of pulmonary hypertension. Pulmonary hypertension is high blood pressure in the pulmonary arteries that carry unoxygenated blood from the right ventricle of the heart to the lungs. Pulmonary hypertension results from constriction, or tightening, of the blood vessels that supply blood to the lungs. Consequently, it becomes difficult for blood to pass through the lungs, making it harder for the heart to pump blood forward. This stress on the heart leads to enlargement of the heart and eventually fluid can build up in the liver and tissues, such as in the legs. Affected patients can sometimes notice increasing shortness of breath and dizziness.
There is a growing body of evidence suggesting a potential therapeutic role for this sildenafil in patients with primary pulmonary hypertension. Studies are ongoing regarding this area.
Our hypothesis is that chronic oral sildenafil will successfully reduce pulmonary artery pressures by at least 25% (reduction in mean pulmonary artery pressure) and could be an effective treatment for PTPH, especially in candidates for liver transplantation
Primary Hypothesis To measure the effects of a single dose of sildenafil on pulmonary arterial pressure in patients with PTPH
Secondary Hypothesis To measure the effects of chronic (3 month) treatment with sildenafil on pulmonary arterial pressure, safety, and tolerability in patients with PTPH
Detailed description
This is a single center (only takes place at University of Chicago), open-label (doctor and subject know that the subject is taking the experimental drut), pilot study to evaluate the effects of sildenafil on pulmonary artery pressures in patients with portopulmonary hypertension.
Patients who are diagnosed with PTPH after having routine care right heart catheterization will be asked if they are interested in participating. Approximately ten subjects will be enrolled. Subjects will undergo the following experimental procedures as part of their participation in this study: blood laboratory tests, medical history, physical exam, inhaled nitric oxide test, study drug (sildenafil) administration, and a pill count.
Sildenafil will be given to these patients 3 times a day for a 12 week period to see if the study drug can lower their pulmonary artery pressures by at least 25%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Candidates for enrollment in this clinical trial are limited to adult patients diagnosed with severe portopulmonary hypertension (PTPH). Specifically, other causes of pulmonary hypertension (PH) such as left ventricular dysfunction, valvular heart disease, chronic lung disease, chronic thromboembolic disease, chronic hypoxemia, rheumatologic conditions, and significant untreated obstructive sleep apnea will be excluded in the usual fashion in patients with underlying portal hypertension and usually cirrhosis. The diagnosis of pulmonary hypertension will be confirmed by invasive hemodynamic measurements (i.e. right heart catheterization) and severe PH is defined as a mean pulmonary artery pressure (MPAP) >35 mmHg. If evidence of right ventricular (RV) dysfunction is present (RV dilation, reduced RV ejection fraction (EF), or elevated RV end-diastolic pressure (>10 mmHg) and the MPAP is 30-35 mmHg, then the patient may be enrolled.
- Study participants will be selected from those patients referred for hemodynamic assessment of pulmonary hypertension, such as potential liver transplant recipients. They must be capable of giving informed consent. The University of Chicago referring physician will be contacted for concurrence of agreement.
Key exclusion criteria (1 listed)
- Patients with pulmonary arterial hypertension, but not portopulmonary hypertension will be excluded. Patients will be excluded from consideration if they do not have severe PTPH, if invasive hemodynamic assessment is contraindicated, or if there are any contraindications to sildenafil. Patients with unstable coronary syndromes or otherwise significant unrevascularized coronary artery disease and myocardial ischemia as determined by cardiac stress testing and/or coronary angiography will also be excluded. Moribund patients will not be considered for enrollment.
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 |
|---|---|---|
| sildenafil | Drug | – |
Primary outcome
Outcome measurement will consist of comparing baseline to treatment hemodynamics both after a single dose and chronic therapy in terms of absolute response as well as the presence of a "significant response" defined as at least a 25% reduction in mean
Results and safety
The study was stopped early (reason given: Unable to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
Allen Anderson, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sildenafil in people with Pulmonary Hypertension, run by University of Chicago at 1 site in United States.
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 2 inclusion and 1 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 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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: Unable to complete study). 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?
Outcome measurement will consist of comparing baseline to treatment hemodynamics both after a single dose and chronic therapy in terms of absolute response as well as the presence of a "significant response" defined as at least a 25% reduction in mean. 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 8 Oct 2013.