Pulmonary Arterial HypertensionPhase 4NCT02253394
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
A Phase 4 study testing Ambrisentan plus Spironolactone in people with Pulmonary Arterial Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps every minute), right ventricle function and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Ambrisentan plus Spironolactone
- 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
- 1 siteUnited States
- Study dates
- Sep 2015to Feb 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Voluntarily gives informed consent to participate in the study.
- Right heart catheterization demonstrating conventional mean pulmonary artery pressure (mPAP) >25, pulmonary vascular resistance (PVR) >3.0 Wood Units, pulmonary capillary wedge pressure (PCWP) <16 mmHg within two years of enrollment
- Subject is 18 years of age or older at Screening.
- Diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with Connective Tissue Disease (CTD), PAH associated with repaired/unrepaired congenital systemic-to-pulmonary shunt, Portopulmonary hypertension or PAH associated with HIV infection.
- New York Heart Association Functional Class II or III
- Stable therapy with ambrisentan 5 or 10 mg every day for > 90 days.
- Baseline 6-Minute Walk Distance 50-450m
Who cannot join
- Substantial Primary Lung disease
- forced expiratory volume at one second (FEV-1)/forced vital capacity (FVC) <0.6 and FEV-1 <70% predicted
- diffusing capacity of lung for carbon monoxide (DLCO) <30% predicted
- Pulmonary fibrosis
- Left ventricular ejection fraction < 50%
- Pulmonary capillary wedge pressure > 16 mm Hg
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- Aortic valve disease
- Ischemic heart disease
- Systemic hypotension (SBP <90 mm Hg)
- Co-existing treatment with other endothelin receptor antagonists or prostacyclin analogues
- New York Heart Association Functional Class IV
- Chronic thromboembolic pulmonary hypertension
- Known or suspected pulmonary veno-occlusive disease
- Serum creatinine >2.0 mg/dL in women, Serum creatinine >2.5 mg/dL in men
- Baseline serum potassium >5.0 milliequivalent (mEq)/L
- Participation in ongoing drug/intervention-based clinical trial
- Pregnancy
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)
The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps every minute), right ventricle function and quality of life.
Read the detailed description
A prospective, double blind, placebo-controlled clinical study involving 30 patients with World Health Organization (WHO) Group 1 pulmonary arterial hypertension being treated with ambrisentan randomized to receive placebo or spironolactone (50 mg/d) for 90 days using a cross-over trial design.
Eligible participants will be randomized to receive placebo or spironolactone (50 mg/d) for 90 days (Phase I). At the completion of Phase I, participants will undergo repeat end-point assessment followed by a 21-day drug washout period. Then, the 90 day crossover phase of the trial will occur (Phase II), in which participants randomized to placebo in Phase I will be treated with spironolactone (50 mg/d) in Phase II and vice versa. At the conclusion of Phase II, end-point measures are reassessed.
Spironolactone is a diuretic used in treatment of PAH patients. Spironolactone is usually added to medical treatment when doses of Lasix/Torsemide are increased and patients are at risk for hypokalemia.
Study procedures being done for this research study are the standard procedures performed on all PAH patients when they are in clinic for follow-up except for the Cardiopulmonary Exercise Test (CPET) with Innocor.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Ambrisentan plus Spironolactone, Ambrisentan plus Placebo
- Keywords
- Pulmonary Arterial Hypertension (PAH), Ambrisentan, Spironolactone, Selective Endothelin A (ETA) inhibition, Aldosterone antagonism, Cardiac output (CO), Right ventricular (RV) function, Heart failure, Quality of life, Pro-inflammatory cytokine, Interleukin-6 (IL-6), Troponin-I, N-terminal pro-brain natriuretic peptide (NT-BNP), Collagen metabolism, N-terminal procollagen type I, Collagen III, Echocardiography, WHO Functional Class, Cardiopulmonary Exercise Test with Innocor, Peak oxygen consumption (pVO2)
- Medical subject headings
- Pulmonary Arterial Hypertension, Inhibition, Psychological, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambrisentan plus SpironolactoneDrug
Also called Letairis plus Aldactone
Cardiopulmonary fitness
Ambrisentan plus PlaceboDrug
Also called Letairis
Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness
| Study group | Role | What they receive |
|---|---|---|
| AMB + Spiro, Cardiopulmonary fitness | Active comparator | Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD Receives: Drug: Ambrisentan plus Spironolactone |
| Placebo Cardiopulmonary fitness | Placebo comparator | Placebo mimics spironolactone 50 mg and will be taken QD Receives: Drug: Ambrisentan plus Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output
Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.
Measured: Up to average of 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Bradley Maron, MD, Brigham and Women's Hospital
- Investigators
- Bradley Maron, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253394
- Sponsor's protocol ID
- CAPS_PAH
- Status last verified
- Nov 2019
- First submitted
- 17 Sep 2014
- Last updated
- 15 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)
- ClinicalTrials.gov ID
- NCT02253394
- Acronym / sponsor ID
- CAPS_PAH
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension (PAH), Ambrisentan, Spironolactone, Selective Endothelin A (ETA) inhibition, Aldosterone antagonism, Cardiac output (CO), Right ventricular (RV) function, Heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 15 Nov 2019
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 find out if spironolactone added to ambrisentan for Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps every minute), right ventricle function and quality of life.
Detailed description
A prospective, double blind, placebo-controlled clinical study involving 30 patients with World Health Organization (WHO) Group 1 pulmonary arterial hypertension being treated with ambrisentan randomized to receive placebo or spironolactone (50 mg/d) for 90 days using a cross-over trial design.
Eligible participants will be randomized to receive placebo or spironolactone (50 mg/d) for 90 days (Phase I). At the completion of Phase I, participants will undergo repeat end-point assessment followed by a 21-day drug washout period. Then, the 90 day crossover phase of the trial will occur (Phase II), in which participants randomized to placebo in Phase I will be treated with spironolactone (50 mg/d) in Phase II and vice versa. At the conclusion of Phase II, end-point measures are reassessed.
Spironolactone is a diuretic used in treatment of PAH patients. Spironolactone is usually added to medical treatment when doses of Lasix/Torsemide are increased and patients are at risk for hypokalemia.
Study procedures being done for this research study are the standard procedures performed on all PAH patients when they are in clinic for follow-up except for the Cardiopulmonary Exercise Test (CPET) with Innocor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMB + Spiro, Cardiopulmonary fitness | Active comparator | Drug: Ambrisentan plus SpironolactoneAmbrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD |
| Placebo Cardiopulmonary fitness | Placebo comparator | Drug: Ambrisentan plus PlaceboPlacebo mimics spironolactone 50 mg and will be taken QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily gives informed consent to participate in the study.
- Right heart catheterization demonstrating conventional mean pulmonary artery pressure (mPAP) >25, pulmonary vascular resistance (PVR) >3.0 Wood Units, pulmonary capillary wedge pressure (PCWP) <16 mmHg within two years of enrollment
- Subject is 18 years of age or older at Screening.
- Diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with Connective Tissue Disease (CTD), PAH associated with repaired/unrepaired congenital systemic-to-pulmonary shunt, Portopulmonary hypertension or PAH associated with HIV infection.
- New York Heart Association Functional Class II or III
Key exclusion criteria (18 listed)
- Substantial Primary Lung disease
- Left ventricular ejection fraction < 50%
- Pulmonary capillary wedge pressure > 16 mm Hg
- Aortic valve disease
- Ischemic heart disease
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 |
|---|---|---|
| Ambrisentan plus SpironolactoneAlso: Letairis plus AldactoneCardiopulmonary fitness | Drug | AMB + Spiro, Cardiopulmonary fitness |
| Ambrisentan plus PlaceboAlso: LetairisPlacebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness | Drug | Placebo Cardiopulmonary fitness |
Primary outcome
Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output
Time frame: Up to average of 20 min
Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bradley Maron, MD principal investigator
Brigham and Women's Hospital
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 Ambrisentan plus Spironolactone in people with Pulmonary Arterial Hypertension, run by Brigham and Women's Hospital 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 7 inclusion and 18 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 15 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 15 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output (time frame: Up to average of 20 min). 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 15 Nov 2019.