Pulmonary Arterial HypertensionNCT00593905
Pharmacogenomics in Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by West Penn Allegheny Health System at 1 site in United States.
Trial summary
Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if associations exist between the efficacy and toxicity of sitaxsentan, bosentan, and ambrisentan and several gene polymorphisms in several key disease-specific and therapy specific genes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, PAH WHO Group I
- What is being tested?
- Sitaxsentan and Bosentan, Ambrisentan
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2012
- Phase
- Observational
- 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
Study population: Patients must have been diagnosed with WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial or Associated with (APAH) Collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, Drugs and toxins , other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy) Associated with significant venous or capillary involvement, Pulmonary veno-occlusive disease, Pulmonary-capillary hemangiomatosis. Patients currently therapy must include sitaxsentan, bosentan, or ambrisentan OR patients must have previously been treated with sitaxsentan, bosentan or ambrisentan for 4 months or longer.
Who may be able to join
- GROUP 1
- Patients have to be currently enrolled or previously enrolled in STRIDE FPH01, FPH01-XC FPH02, FPH02x, FPH03, FPH04 or FPH06.
- WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial, Associated with (APAH) Collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, Drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy) Associated with significant venous or capillary involvement, Pulmonary veno-occlusive disease, Pulmonary-capillary hemangiomatosis.
- GROUP 2
- Patients currently receiving bosentan or ambrisentan OR who have previously received bosentan or ambrisentan for greater than 4 (four) months.
- WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial, Associated with (APAH), collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, or splenectomy), associated with significant venous or capillary involvement, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis.
Who cannot join
- GROUP 1
- Not enrolled in the Encysive Pharmaceutical's STRIDE study(sitaxsentan).
- Known infectious disease (HIV, Hepatitis).
- GROUP 2
- Never enrolled in the STRIDE study for sitaxsentan patients.
- Not currently or previously on bosentan or ambrisentan.
- Patients who were previously on bosentan or ambrisentan must have been on bosentan or ambrisentan for greater than 4 months.
- Known infectious disease (HIV, Hepatitis).
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Pharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific Genes
Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if associations exist between the efficacy and toxicity of sitaxsentan, bosentan, and ambrisentan and several gene polymorphisms in several key disease-specific and therapy specific genes. Also characterized is the relationship between these polymorphisms and the severity of Pulmonary Arterial Hypertension using either baseline hemodynamic or clinical surrogates for disease severity.
Hypothesis: Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial Hypertension therapy as well as development/severity of PAH via their effect on PA remodeling, drug response, or metabolism.
This study requires a one time 8.5 ml blood sample and clinical data to be obtained at initiation of therapy, 4 months after initiation of therapy and 12 months after initiation of therapy.
Read the detailed description
This study will make use of a large population of well defined patients with Pulmonary Arterial Hypertension who were enrolled in Encysive Pharmaceutical's STRIDE clinical trials or who have received bosentan or ambrisentan for 4 months or longer. This international study constitutes the largest clinical study of this deadly disease and in such has great potential to alter the clinical practice by revealing novel gene-drug interactions. This study tests the hypothesis by executing the following aims:
Aim 1: Determine in Pulmonary Arterial Hypertension (the relationship between known disease-specific polymorphisms (Serotonin transporter gene and PAI HindIII) and variants in BMPR2 and SMAD4 with several well-defined clinical efficacy endpoints of sitaxsentan, bosentan, and ambrisentan therapy.
Aim 2: Determine in Pulmonary Arterial Hypertension the relationship between existing potentially "therapy-specific" polymorphisms in the ET-1, ETAR, ETBR, NPR-C, prostacyclin receptor and prostacyclin synthase with several well-defined clinical efficacy endpoints of sitaxsentan, bosentan, and ambrisentan therapy.
Aim 3: Characterize the relationship between any treatment effect, these polymorphisms and PAH severity, using either clinical data or clinical surrogates for disease activity.
*This study was funded by the NIH from 2005 - 2009. In August 2009 a no-cost extension was granted and this study continued until the end of July 2010. Currently the study is still active and does still have several active sites participating; however, the study is funded by the internal institution and there is no contributing federal funding.*
- Being tested
- Sitaxsentan, Bosentan, Ambrisentan
- Keywords
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, Pharmacogenomics, DNA Testing, sitaxsentan, bosentan, ambrisentan, elevated pulmonary artery pressures, Letairis, Tracleer, Thelin, Primary Pulmonary Hypertension, Pulmonary Artery
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitaxsentanDrug
Also called Sitaxsentan-Thelin
Sitaxsentan sodium 100 mg tablet every morning
Bosentan, AmbrisentanDrug
Also called Bosentan-Tracleer, Ambrisentan-Letairis
Bosentan 125 mg tablet twice daily Ambrisentan 5-10 mg tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | GROUP 1
1. Patients have to be currently enrolled or previously enrolled in STRIDE FPH01, FPH01-XC FPH02, FPH02x, FPH03, FPH04 or FPH06.
2. WHO Group 1 Pulmonary arterial Hypertension: Idiopathic, Familial, Associated with (APAH) Collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, Drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy) Associated with significant venous or capillary involvement, Pulmonary veno-occlusive disease, Pulmonary-capillary hemangiomatosis. Receives: Drug: Sitaxsentan | |
| Group 2 | Group 2
1. Patients currently receiving bosentan or ambrisentan OR who have previously received bosentan or ambrisentan for greater than 4 (four) months.
2. WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial, Associated with (APAH), collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, or splenectomy), associated with significant venous or capillary involvement, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis. Receives: Drug: Bosentan, Ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
Measured: 12 months after initiation of drug therapy
Secondary outcomes (6)
Hemodynamics - Right Heart Catheterization
Measured: 12 months after intitation of drug therapy
Borg
Measured: 12 months after initiation of drug therapy
Functional Class - FC
Measured: 12 months after intitation of drug therapy
Toxicities
Measured: 12 months after initiation of drug therapy
Time of Clinical Worsening
Measured: 12 months after initiation of drug therapy
Decline in WHO Functional Class
Measured: 12 months after initiation of drug therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJul 2005
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: study not started not an ACT
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Baylor College of Medicine, Emory University, University of Chicago, Johns Hopkins University, Tufts Medical Center, Sir Mortimer B. Davis - Jewish General Hospital, London Health Sciences Centre, University of Maryland, College Park, University of California, San Francisco, University of Calgary, Chest Medical Associates, Columbia University, Lung Diagnostics, Ltd., Duke University, University of California, Los Angeles, Latter Day Saints Hospital, Louisiana State University Health Sciences Center in New Orleans, Massachusetts General Hospital, Mayo Clinic, Medical College of Wisconsin, Southeastern Lung Care, Suncoast Lung Center, Children's Hospital Colorado, University Hospitals Cleveland Medical Center, University of Colorado, Denver, University of Michigan, University of Pittsburgh Medical Center, University of Southern California, The University of Texas Medical Branch, Galveston, Vanderbilt University, Wayne State University, Ohio State University, University of Alabama at Birmingham, Washington University School of Medicine, Sentara Norfolk General Hospital, University of Texas Southwestern Medical Center, Bay Area Chest Physicians
- Responsible party
- Principal investigator, Dawnmarie DeFazio, West Penn Allegheny Health System
- Investigators
- Raymond L Benza, MD, Principal investigator, Allegheny General Hospital/Allegheny-Singer Research Institute of West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593905
- Sponsor's protocol ID
- RC-4590
- Other IDs
- RC #4590
- Status last verified
- Nov 2021
- First submitted
- 3 Jan 2008
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific Genes
- ClinicalTrials.gov ID
- NCT00593905
- Acronym / sponsor ID
- RC-4590
- Keywords
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, Pharmacogenomics, DNA Testing, sitaxsentan, bosentan, ambrisentan, elevated pulmonary artery pressures
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study not started not an ACT
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Baylor College of Medicine, Emory University, University of Chicago, Johns Hopkins University, Tufts Medical Center, Sir Mortimer B. Davis - Jewish General Hospital, London Health Sciences Centre, University of Maryland, College Park, University of California, San Francisco, University of Calgary, Chest Medical Associates, Columbia University, Lung Diagnostics, Ltd., Duke University, University of California, Los Angeles, Latter Day Saints Hospital, Louisiana State University Health Sciences Center in New Orleans, Massachusetts General Hospital, Mayo Clinic, Medical College of Wisconsin, Southeastern Lung Care, Suncoast Lung Center, Children's Hospital Colorado, University Hospitals Cleveland Medical Center, University of Colorado, Denver, University of Michigan, University of Pittsburgh Medical Center, University of Southern California, The University of Texas Medical Branch, Galveston, Vanderbilt University, Wayne State University, Ohio State University, University of Alabama at Birmingham, Washington University School of Medicine, Sentara Norfolk General Hospital, University of Texas Southwestern Medical Center, Bay Area Chest Physicians
- Study start
- Jul 2005
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Jan 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.
Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if associations exist between the efficacy and toxicity of sitaxsentan, bosentan, and ambrisentan and several gene polymorphisms in several key disease-specific and therapy specific genes. Also characterized is the relationship between these polymorphisms and the severity of Pulmonary Arterial Hypertension using either baseline hemodynamic or clinical surrogates for disease severity.
Hypothesis: Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial Hypertension therapy as well as development/severity of PAH via their effect on PA remodeling, drug response, or metabolism.
This study requires a one time 8.5 ml blood sample and clinical data to be obtained at initiation of therapy, 4 months after initiation of therapy and 12 months after initiation of therapy.
Detailed description
This study will make use of a large population of well defined patients with Pulmonary Arterial Hypertension who were enrolled in Encysive Pharmaceutical's STRIDE clinical trials or who have received bosentan or ambrisentan for 4 months or longer. This international study constitutes the largest clinical study of this deadly disease and in such has great potential to alter the clinical practice by revealing novel gene-drug interactions. This study tests the hypothesis by executing the following aims:
Aim 1: Determine in Pulmonary Arterial Hypertension (the relationship between known disease-specific polymorphisms (Serotonin transporter gene and PAI HindIII) and variants in BMPR2 and SMAD4 with several well-defined clinical efficacy endpoints of sitaxsentan, bosentan, and ambrisentan therapy.
Aim 2: Determine in Pulmonary Arterial Hypertension the relationship between existing potentially "therapy-specific" polymorphisms in the ET-1, ETAR, ETBR, NPR-C, prostacyclin receptor and prostacyclin synthase with several well-defined clinical efficacy endpoints of sitaxsentan, bosentan, and ambrisentan therapy.
Aim 3: Characterize the relationship between any treatment effect, these polymorphisms and PAH severity, using either clinical data or clinical surrogates for disease activity.
*This study was funded by the NIH from 2005 - 2009. In August 2009 a no-cost extension was granted and this study continued until the end of July 2010. Currently the study is still active and does still have several active sites participating; however, the study is funded by the internal institution and there is no contributing federal funding.*
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: SitaxsentanGROUP 1 1. Patients have to be currently enrolled or previously enrolled in STRIDE FPH01, FPH01-XC FPH02, FPH02x, FPH03, FPH04 or FPH06. 2. WHO Group 1 Pulmonary arterial Hypertension: Idiopathic, Familial, Associated with (APAH) Collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, Drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy) Associated with significant venous or capillary involvement, Pulmonary veno-occlusive disease, Pulmonary-capillary hemangiomatosis. |
| Group 2 | – | Drug: Bosentan, AmbrisentanGroup 2 1. Patients currently receiving bosentan or ambrisentan OR who have previously received bosentan or ambrisentan for greater than 4 (four) months. 2. WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial, Associated with (APAH), collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, or splenectomy), associated with significant venous or capillary involvement, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients must have been diagnosed with WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial or Associated with (APAH) Collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, Drugs and toxins , other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy) Associated with significant venous or capillary involvement, Pulmonary veno-occlusive disease, Pulmonary-capillary hemangiomatosis. Patients currently therapy must include sitaxsentan, bosentan, or ambrisentan OR patients must have previously been treated with sitaxsentan, bosentan or ambrisentan for 4 months or longer.
Key inclusion criteria (6 listed)
- GROUP 1
- Patients have to be currently enrolled or previously enrolled in STRIDE FPH01, FPH01-XC FPH02, FPH02x, FPH03, FPH04 or FPH06.
- WHO Group 1 Pulmonary Arterial Hypertension: Idiopathic, Familial, Associated with (APAH) Collagen vascular disease, congenital systemic-to-pulmonary shunts, portal hypertension, Drugs and toxins (e.g., anorexigens, rapeseed oil, L-tryptophan, methamphetamine, and cocaine), other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy) Associated with significant venous or capillary involvement, Pulmonary veno-occlusive disease, Pulmonary-capillary hemangiomatosis.
- GROUP 2
- Patients currently receiving bosentan or ambrisentan OR who have previously received bosentan or ambrisentan for greater than 4 (four) months.
Key exclusion criteria (8 listed)
- GROUP 1
- Not enrolled in the Encysive Pharmaceutical's STRIDE study(sitaxsentan).
- Known infectious disease (HIV, Hepatitis).
- GROUP 2
- Never enrolled in the STRIDE study for sitaxsentan patients.
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 |
|---|---|---|
| SitaxsentanAlso: Sitaxsentan-ThelinSitaxsentan sodium 100 mg tablet every morning | Drug | Group 1 |
| Bosentan, AmbrisentanAlso: Bosentan-Tracleer, Ambrisentan-LetairisBosentan 125 mg tablet twice daily Ambrisentan 5-10 mg tablet once daily | Drug | Group 2 |
Primary outcome
6 Minute Walk Test
Time frame: 12 months after initiation of drug therapy
6 secondary outcomes
Hemodynamics - Right Heart Catheterization
Time frame: 12 months after intitation of drug therapy
Borg
Time frame: 12 months after initiation of drug therapy
Functional Class - FC
Time frame: 12 months after intitation of drug therapy
Toxicities
Time frame: 12 months after initiation of drug therapy
Time of Clinical Worsening
Time frame: 12 months after initiation of drug therapy
Decline in WHO Functional Class
Time frame: 12 months after initiation of drug therapy
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 9 Dec 2021.
- Pulmonary Hypertension Association websiteLink provided by the sponsor.
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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.
Raymond L Benza, MD principal investigator
Allegheny General Hospital/Allegheny-Singer Research Institute of West Penn Allegheny Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by West Penn Allegheny Health System 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 6 inclusion and 8 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 9 Dec 2021. 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.
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 Test (time frame: 12 months after initiation of drug therapy). 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 9 Dec 2021.