Pulmonary Arterial HypertensionPhase 4NCT00625079
Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil
A Phase 4 study testing sildenafil in people with Pulmonary Arterial Hypertension and Idiopathic Pulmonary Fibrosis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2009
- Phase
- Phase 4
- 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
- Patients with Idiopathic Pulmonary Fibrosis referred for lung transplantation at our medical center
- Minimal 6 minute walk distance of 50 meters; must be able to conduct supine exercise during heart catheterization
Who cannot join
- Non ambulatory
- Prior adverse reaction/allergy to sildenafil or other PDE-5 Inhibitors
- Any other pulmonary vasodilator within one month of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
David Geffen School of Medicine UCLA
Los Angeles, California, 90095-1690
About this study
Official title: Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study
Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that sildenafil may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.
Read the detailed description
The purpose of this study is to evaluate the use of sildenafil in patients with pulmonary fibrosis and PH being considered for lung transplantation. We hypothesize that not only will sildenafil improve functionality and QOL in the pre-transplant setting but it may also improve primary graft dysfunction after lung transplantation.
- Conditions
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Pulmonary Hypertension
- Being tested
- sildenafil
- Keywords
- pulmonary hypertension, pulmonary arterial hypertension, interstitial lung disease, idiopathic pulmonary fibrosis
- Medical subject headings
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
Also called Revatio
the dose of sildenafil will be 20mg three times per day (orally)
| Study group | Role | What they receive |
|---|---|---|
| Pre-transplant placebo | Placebo comparator | There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH Receives: Drug: sildenafil |
| Pre-transplant sildenafil | Experimental | There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug. Receives: Drug: sildenafil |
| Pre-transplant no PAH-specific therapy | No intervention | this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk distance (6MWD) change from Baseline
ATS guideline based 6MW distance
Measured: 6 months
Secondary outcomes (4)
Right heart catheterization hemodynamics
pulmonary hemodynamics via invasive right heart catheterization
Measured: initial right heart catheterization compared to catheterization done on day of lung transplantation; we will specifically compare mean pulmonary artery pressure, pulmonary vascular resistance, and pulmonary artery wedge pressure
Chemokine analysis on peripheral blood
evaluation of a group of chemokines before and after the intervention in each arm
Measured: the chemokines will be quantified and compared between study entry and the time point just prior to lung transplantation
Quality of life assessment
SF-36 (short-form 36)
Measured: study entry compared to 6 months or at the time of lung transplantation (whichever comes first); there is a 0-100 scoring scale and the lower the score, the more disability
Quality of life assessment in the context of dyspnea
Saint George Respiratory Questionnaire (SGRQ)
Measured: the SGRQ will be be compared at two time points, study entry and at 6 months or the time of transplantation (whichever comes first); scores range from 0 to 100 and higher scores indicate more limitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2007
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: inclusion/exclusion criteria limited enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Rajan Saggar, MD, Study director, David Geffen School of Medicine, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625079
- Sponsor's protocol ID
- IPF/PH
- Status last verified
- Mar 2018
- First submitted
- 19 Feb 2008
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT00625079
- Acronym / sponsor ID
- IPF/PH
- Conditions
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Pulmonary Hypertension
- Keywords
- pulmonary hypertension, pulmonary arterial hypertension, interstitial lung disease, idiopathic pulmonary fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inclusion/exclusion criteria limited enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2007 (actual)
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 28 Feb 2008 (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.
Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that sildenafil may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.
Detailed description
The purpose of this study is to evaluate the use of sildenafil in patients with pulmonary fibrosis and PH being considered for lung transplantation. We hypothesize that not only will sildenafil improve functionality and QOL in the pre-transplant setting but it may also improve primary graft dysfunction after lung transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-transplant placebo | Placebo comparator | Drug: sildenafilThere are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH |
| Pre-transplant sildenafil | Experimental | Drug: sildenafilThere are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug. |
| Pre-transplant no PAH-specific therapy | No intervention | –this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Idiopathic Pulmonary Fibrosis referred for lung transplantation at our medical center
- Minimal 6 minute walk distance of 50 meters; must be able to conduct supine exercise during heart catheterization
Key exclusion criteria (3 listed)
- Non ambulatory
- Prior adverse reaction/allergy to sildenafil or other PDE-5 Inhibitors
- Any other pulmonary vasodilator within one month of 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 |
|---|---|---|
| sildenafilAlso: Revatiothe dose of sildenafil will be 20mg three times per day (orally) | Drug | Pre-transplant placebo, Pre-transplant sildenafil |
Primary outcome
6 minute walk distance (6MWD) change from Baseline
Time frame: 6 months
ATS guideline based 6MW distance
4 secondary outcomes
Right heart catheterization hemodynamics
Time frame: initial right heart catheterization compared to catheterization done on day of lung transplantation; we will specifically compare mean pulmonary artery pressure, pulmonary vascular resistance, and pulmonary artery wedge pressure
Chemokine analysis on peripheral blood
Time frame: the chemokines will be quantified and compared between study entry and the time point just prior to lung transplantation
Quality of life assessment
Time frame: study entry compared to 6 months or at the time of lung transplantation (whichever comes first); there is a 0-100 scoring scale and the lower the score, the more disability
Quality of life assessment in the context of dyspnea
Time frame: the SGRQ will be be compared at two time points, study entry and at 6 months or the time of transplantation (whichever comes first); scores range from 0 to 100 and higher scores indicate more limitation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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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.
Rajan Saggar, MD study director
David Geffen School of Medicine, UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sildenafil in people with Pulmonary Arterial Hypertension and Idiopathic Pulmonary Fibrosis, run by University of California, Los Angeles 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 3 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: withdrawn, as of the sponsor's last update on 1 May 2018. 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. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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?
6 minute walk distance (6MWD) change from Baseline (time frame: 6 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 1 May 2018.