Pre-Pulmonary Atrial HypertensionAMERICA-PAHNCT02169752
Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension
A study testing Ambrisentan in people with Pre-Pulmonary Atrial Hypertension, run by National Jewish Health at 1 site in United States.
Trial summary
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pre-Pulmonary Atrial Hypertension
- What is being tested?
- Ambrisentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 25 May 2017
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years, < 80 years
- Systemic sclerosis with any of the following features:
- Duration of Raynaud's phenomena >8 years
- Anticentromere antibody positivity
- isolated nucleolar-pattern ANA positivity
- Extensive telangiectasias
Show all 13Show fewer
- DLCO < 60% in the absence of extensive ILD
- FVC%/DLCO% >1.6
- Unexplained dyspnea
- Right heart catheterization-proven pre PAH (mean PAP 20-25 mmHg and pulmonary capillary wedge pressure <15 mmHg)
- Systolic blood pressure >100 mmHg
- Reliable contraception for women of childbearing age
- Informed consent
Who cannot join
- < 18 years or > 80 years
- Left ventricular ejection fraction < 55%
- Systolic or diastolic left ventricular congestive heart failure
- Liver disease (abnormal AST/ALT, chronic hepatitis, or cirrhosis)
- Extensive ILD or FVC< 60%
- Pregnant
- Breast-feeding women
- Cyclosporine use
Trial locations and contacts
1 site in 1 country.
About this study
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.
Read the detailed description
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.
Pre-pulmonary arterial hypertension is a borderline elevation in blood pressure in the lungs. Pre-pulmonary arterial hypertension is not currently treated with the drug therapies that are used for pulmonary arterial hypertension. It represents a group of patients that are at risk for developing pulmonary arterial hypertension.
The administration of ambrisentan is the experimental part of this study. Ambrisentan has not been approved by the FDA for use of improving right ventricle function in people with pre-pulmonary arterial hypertension. You will still receive your normal clinical care.
The purpose of this study is to learn more about ambrisentan and its role in treating systemic sclerosis-associated pre-pulmonary arterial hypertension. Ambrisentan is already approved for use in people with systemic sclerosis-associated pulmonary arterial hypertension, but this study wants to research its role in people with pre-pulmonary arterial hypertension.
- Conditions
- Pre-Pulmonary Atrial Hypertension
- Being tested
- Ambrisentan
- Keywords
- Pre-Pulmonary Atrial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbrisentanDrug
Also called Letairis
Subjects will be randomized 1:1 ratio according to computer generated random numbers to receive either "placebo" or ambrisentan 5mg daily for one month followed by 10 mg daily for the 5 months in a double-blinded manner.
| Study group | Role | What they receive |
|---|---|---|
| Ambrisentan | Active comparator | Subjects will be randomly assigned in a 1:1 ration according to the computer generated random numbers to receive either placebo (sugar pill) or ambrisentan. Receives: Drug: Ambrisentan |
| Placebo | Placebo comparator | Subjects will be randomly assigned in a 1:1 ration according to the computer generated random numbers to receive either placebo (sugar pill) or ambrisentan. Receives: Drug: Ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in right ventricular (RV) myocardio strain > 2%
Assess for tolerance, gas exchange, and therapeutic benefit, resting oximetry, six minute walk with oximetry, pulmonary function testing with diffusion capacity (DLCO), and functional class will be assessed prior to ambrisentan initiation, and 1,3, and 6 months.
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startSep 2012
- Primary completion25 May 2017
- Study completion25 May 2017
Why it stopped: PI left National Jewish Health
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Pulmonary Atrial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brett Fenster, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169752
- Sponsor's protocol ID
- HS-2716
- Acronym
- AMERICA-PAH
- Status last verified
- Jan 2021
- First submitted
- 6 May 2014
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02169752
- Acronym / sponsor ID
- AMERICA-PAH / HS-2716
- Conditions
- Pre-Pulmonary Atrial Hypertension
- Keywords
- Pre-Pulmonary Atrial Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left National Jewish Health
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 23 Jun 2014 (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.
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.
Detailed description
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.
Pre-pulmonary arterial hypertension is a borderline elevation in blood pressure in the lungs. Pre-pulmonary arterial hypertension is not currently treated with the drug therapies that are used for pulmonary arterial hypertension. It represents a group of patients that are at risk for developing pulmonary arterial hypertension.
The administration of ambrisentan is the experimental part of this study. Ambrisentan has not been approved by the FDA for use of improving right ventricle function in people with pre-pulmonary arterial hypertension. You will still receive your normal clinical care.
The purpose of this study is to learn more about ambrisentan and its role in treating systemic sclerosis-associated pre-pulmonary arterial hypertension. Ambrisentan is already approved for use in people with systemic sclerosis-associated pulmonary arterial hypertension, but this study wants to research its role in people with pre-pulmonary arterial hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambrisentan | Active comparator | Drug: AmbrisentanSubjects will be randomly assigned in a 1:1 ration according to the computer generated random numbers to receive either placebo (sugar pill) or ambrisentan. |
| Placebo | Placebo comparator | Drug: AmbrisentanSubjects will be randomly assigned in a 1:1 ration according to the computer generated random numbers to receive either placebo (sugar pill) or ambrisentan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age >18 years, < 80 years
- Systemic sclerosis with any of the following features:
- Right heart catheterization-proven pre PAH (mean PAP 20-25 mmHg and pulmonary capillary wedge pressure <15 mmHg)
- Systolic blood pressure >100 mmHg
- Reliable contraception for women of childbearing age
Key exclusion criteria (8 listed)
- < 18 years or > 80 years
- Left ventricular ejection fraction < 55%
- Systolic or diastolic left ventricular congestive heart failure
- Liver disease (abnormal AST/ALT, chronic hepatitis, or cirrhosis)
- Extensive ILD or FVC< 60%
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 |
|---|---|---|
| AmbrisentanAlso: LetairisSubjects will be randomized 1:1 ratio according to computer generated random numbers to receive either "placebo" or ambrisentan 5mg daily for one month followed by 10 mg daily for the 5 months in a double-blinded manner. | Drug | Ambrisentan, Placebo |
Primary outcome
Improvement in right ventricular (RV) myocardio strain > 2%
Time frame: 1, 3 and 6 months
Assess for tolerance, gas exchange, and therapeutic benefit, resting oximetry, six minute walk with oximetry, pulmonary function testing with diffusion capacity (DLCO), and functional class will be assessed prior to ambrisentan initiation, and 1,3, and 6 months.
Results and safety
The study was stopped early (reason given: PI left National Jewish Health). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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.
Brett Fenster, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambrisentan in people with Pre-Pulmonary Atrial Hypertension, run by National Jewish Health 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 13 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: stopped early, as of the sponsor's last update on 19 Jan 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. 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.
Are results available for this study?
The study was stopped early (reason given: PI left National Jewish Health). 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?
Improvement in right ventricular (RV) myocardio strain > 2% (time frame: 1, 3 and 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 19 Jan 2021.