Pulmonary Arterial HypertensionES-QuERINCT01623492
Eisenmenger Quality Enhancement Research Initiative
An observational study of Pulmonary Arterial Hypertension, run by Actelion.
Trial summary
Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center, observational, US-based longitudinal program, with enrollment of consecutive Eisenmenger patients who meet enrollment. Patient data will be collected prospectively for three years. 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?
- Subjects with diagnosis of Eisenmenger Syndrome
- Type of treatment
- Vaccines
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 17 Apr 2018
- How long will I take part?
- 3 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.
Who may be able to join
- Male and female patients
- Diagnosis of Eisenmenger syndrome based on right heart catheterization data
- Right to Left intra-cardiac shunting
- PAH
- Need for comprehensive management according to guidelines and peer-reviewed evidence
- Ability and desire to execute the consent for follow up
Who cannot join
- Poor mental function, drug, or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
- Prior inclusion in this program
About this study
Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center, observational, US-based longitudinal program, with enrollment of consecutive Eisenmenger patients who meet enrollment. Patient data will be collected prospectively for three years. Individual physician feedback will be provided on data collected with the purpose of improving the management of patients - quality enhancement research initiative (QuERI) process.
Read the detailed description
Approximately 200 male and female adult patients with a history of Eisenmenger will be recruited from approximately 50 cardiology practices over a period of 18 months and will be followed up every six months for the period of three years. Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study. Participating sites will be asked to maintain a screening log to identify which inclusion or exclusion criteria was not met thus excluding them from the study.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Subjects with diagnosis of Eisenmenger Syndrome
- Keywords
- Eisenmenger
- Medical subject headings
- Pulmonary Arterial Hypertension, Eisenmenger Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects with diagnosis of Eisenmenger SyndromeOther
Also called management of Eisenmenger Syndrome
- Antibiotic recommendation for SBE prophylaxis and influenza vaccine
- Contraception counseling, and recommendations regarding avoidance of pregnancy
- Documentation and prescription of the specific medications:
- Oxygen
- Diuretic
- ASA, Anticoagulant
- CCB, BB, ACEI, ARB
- Iron Supplementation
- Allopurinol
- PAH specific therapy
| Study group | Role | What they receive |
|---|---|---|
| diagnosis of Eisenmenger Syndrome | subjects with diagnosis of Eisenmenger Syndrome Receives: Other: Subjects with diagnosis of Eisenmenger Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the clinical course of patients with Eisenmenger Syndrome
The management of Eisenmenger Syndrome patients over the three year registry period will be compared with established national guidelines. In addition, The Minnesota Living with Heart Failure questionnaire (MLHFQ) will be collected.
Measured: up to 3 years
Secondary outcomes (3)
Characterization of the demographics of patients with Eisenmenger Syndrome
Measured: baseline (visit 1) thru end of study (3 years)
Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome.
Measured: baseline (visit 1) thru end of study (3 years)
Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.
Measured: baseline (visit 1) thru end of study (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study start1 Jul 2012
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
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
- Prospective
- Enrolment
- 193 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Canadian Heart Research Centre
- Responsible party
- Sponsor
- Investigators
- Michael Landzberg, MD, Study chair, Harvard Medical School / Boston Adult Congenital HeartGary Palmer, MD, MBA, Study director, Actelion Pharmaceuticals U.S., Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623492
- Sponsor's protocol ID
- AC-052-435
- Acronym
- ES-QuERI
- Status last verified
- Jan 2025
- First submitted
- 9 May 2012
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eisenmenger Quality Enhancement Research Initiative
- ClinicalTrials.gov ID
- NCT01623492
- Acronym / sponsor ID
- ES-QuERI / AC-052-435
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Eisenmenger
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Collaborators
- Canadian Heart Research Centre
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 20 Jun 2012 (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.
Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center, observational, US-based longitudinal program, with enrollment of consecutive Eisenmenger patients who meet enrollment. Patient data will be collected prospectively for three years. Individual physician feedback will be provided on data collected with the purpose of improving the management of patients - quality enhancement research initiative (QuERI) process.
Detailed description
Approximately 200 male and female adult patients with a history of Eisenmenger will be recruited from approximately 50 cardiology practices over a period of 18 months and will be followed up every six months for the period of three years. Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study. Participating sites will be asked to maintain a screening log to identify which inclusion or exclusion criteria was not met thus excluding them from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnosis of Eisenmenger Syndrome | – | Other: Subjects with diagnosis of Eisenmenger Syndromesubjects with diagnosis of Eisenmenger Syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.
Key inclusion criteria (6 listed)
- Male and female patients
- Diagnosis of Eisenmenger syndrome based on right heart catheterization data
- Right to Left intra-cardiac shunting
- PAH
- Need for comprehensive management according to guidelines and peer-reviewed evidence
Key exclusion criteria (2 listed)
- Poor mental function, drug, or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
- Prior inclusion in this program
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 |
|---|---|---|
| Subjects with diagnosis of Eisenmenger SyndromeAlso: management of Eisenmenger Syndrome1. Antibiotic recommendation for SBE prophylaxis and influenza vaccine 2. Contraception counseling, and recommendations regarding avoidance of pregnancy 3. Documentation and prescription of the specific medications: 1. Oxygen 2. Diuretic 3. ASA, Anticoagulant 4. CCB, BB, ACEI, ARB 5. Iron Supplementation 6. Allopurinol 7. PAH specific therapy | Other | diagnosis of Eisenmenger Syndrome |
Primary outcome
Characterization of the clinical course of patients with Eisenmenger Syndrome
Time frame: up to 3 years
The management of Eisenmenger Syndrome patients over the three year registry period will be compared with established national guidelines. In addition, The Minnesota Living with Heart Failure questionnaire (MLHFQ) will be collected.
3 secondary outcomes
Characterization of the demographics of patients with Eisenmenger Syndrome
Time frame: baseline (visit 1) thru end of study (3 years)
Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome.
Time frame: baseline (visit 1) thru end of study (3 years)
Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.
Time frame: baseline (visit 1) thru end of study (3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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.
Michael Landzberg, MD study chair
Harvard Medical School / Boston Adult Congenital Heart
Gary Palmer, MD, MBA study director
Actelion Pharmaceuticals U.S., Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Actelion.
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 2 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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterization of the clinical course of patients with Eisenmenger Syndrome (time frame: up to 3 years). 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 3 Feb 2025.