Pulmonary HypertensionNCT01646541
Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery
An observational study of Pulmonary Hypertension and Mitral Valve Disease, run by Duke University at 2 sites in United States.
Trial summary
Most patients with mitral valve disease are symptomatic with shortness of breath and a limited activity level prior to mitral valve surgery. Despite surgical repair or replacement of the mitral valve, many patients remain symptomatic with an impaired ability to live an active lifestyle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Mitral Valve Disease
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Dec 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seen in the cardiology, pulmonary hypertension, or cardiac surgery clinics at the enrolling institutions
Who may be able to join
- Age > 18 years
- Greater than 6 months post-mechanical or bioprosthetic mitral valve replacement or mitral valve repair (quadrangular resection, triangular resection, sliding plasty, and/or annuloplasty) surgery
- Dyspnea at rest or with exertion (NYHA II, III, or IV) [Symptomatic Study Group]
- Asymptomatic control group meeting criteria 1 and 2 above
Who cannot join
- Current or prior chronic vasodilator therapy for pulmonary hypertension
- Known collagen vascular disease
- HIV infection: Based on self-report /historical diagnosis
- Portal hypertension
- Prior anorexigen use
- History of corrected or uncorrected intracardiac shunt
Show all 15Show fewer
- Prior pulmonary embolism
- Sickle cell disease
- Left ventricular dysfunction (ejection fraction < 45%)
- Moderate or severe mitral regurgitation
- Moderate aortic stenosis (mean gradient > 25 mm Hg)
- Symptomatic, non-revascularized coronary artery disease
- Evidence of parenchymal lung disease with a TLC < 70% and an FEV1 < 65% of predicted with pulmonary function testing
- Pregnancy - Serum pregnancy test for women of child bearing potential, if cardiac catheterization is needed
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University Medical Center
Chicago, Illinois, 60611
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery: Pilot, Screening Study
Most patients with mitral valve disease are symptomatic with shortness of breath and a limited activity level prior to mitral valve surgery. Despite surgical repair or replacement of the mitral valve, many patients remain symptomatic with an impaired ability to live an active lifestyle. Often after extensive evaluation, no other pulmonary, left ventricular dysfunction, or valvular heart disease is responsible for the continued symptoms, and some of these patients will be limited by persistent pulmonary hypertension (PH) at rest or with exertion that is responsible for limiting their activity level and impacting their quality of their life.
It is our goal in the proposed study to systematically characterize symptomatic and asymptomatic patients greater than six months after mitral valve surgery using clinical data, echocardiographic evaluation, laboratory assessment, and in some patients, invasive hemodynamic measurements. The investigators will screen asymptomatic and symptomatic patients with resting echocardiography and also with echocardiography during exercise, as many patients will exhibit exercise-induced PH following mitral valve surgery. Pulmonary artery (PA) pressure will be estimated from echocardiography using Doppler-derived calculations. If elevated PA pressures are observed with echocardiography, then symptomatic patients will undergo right heart catheterization for invasive pressure measurement, which is the gold-standard for the diagnosis of PH. When PH is present and there is a normal wedge pressure (PCWP) during invasive pressure measurement, further assessment to identify potential candidates for PH therapy will be performed. This involves having patients breathe inhaled nitric oxide, a rapid-acting, pulmonary vasodilator with a short half-life. While breathing inhaled nitric oxide, blood pressure, PA pressure, PCWP, and cardiac output will be monitored to characterize individuals who could benefit symptomatically from pharmacotherapy to treat underlying PH. It is important to note that only a small minority of patients exhibit a positive vasodilator response and those with PH and a normal PCWP without an initial vasodilator response would still be identified as candidates for chronic PH therapy.
The information generated from this proposed research will make a significant contribution to the understanding of PH in a group of patients in whom it has not been previously studied. Scientific reports on the evaluation of patients with PH after mitral valve surgery are almost nonexistent from the modern era. Furthermore, patients with PH due to mitral valve disease have been excluded from clinical trials of agents currently approved by the U.S. Food and Drug Administration (FDA) to treat PH. Therefore, this work will carefully characterize PA pressures in an objective manner in a group of patients following mitral valve surgery who remain limited with respect to their activity levels. In addition, the investigators will gain a better understanding of the frequency with which patients have PH and a normal PCWP, which identifies a cohort of patients who could have an improvement in their symptoms and quality of life with chronic vasodilator treatment.
- Conditions
- Pulmonary Hypertension, Mitral Valve Disease
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic | No dyspnea with exertion greater than 6 months after mitral valve surgery [New York Heart Association (NYHA) Functional Class I] | |
| Symptomatic | Dyspnea with exertion greater than 6 months after mitral valve surgery [New York Heart Association (NYHA) Functional Class II, III, or IV] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pulmonary hypertension
study evaluation period will take several hours to complete the components of the study (clinical evaluation, echocardiogram, etc.) on approximately 2 occasions
Measured: greater than 6 months after mitral valve surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Andrew Wang, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646541
- Sponsor's protocol ID
- Pro00033042
- Status last verified
- May 2017
- First submitted
- 16 Jul 2012
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery: Pilot, Screening Study
- ClinicalTrials.gov ID
- NCT01646541
- Acronym / sponsor ID
- Pro00033042
- Conditions
- Pulmonary Hypertension, Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Northwestern University, Gilead Sciences
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Jul 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.
Most patients with mitral valve disease are symptomatic with shortness of breath and a limited activity level prior to mitral valve surgery. Despite surgical repair or replacement of the mitral valve, many patients remain symptomatic with an impaired ability to live an active lifestyle. Often after extensive evaluation, no other pulmonary, left ventricular dysfunction, or valvular heart disease is responsible for the continued symptoms, and some of these patients will be limited by persistent pulmonary hypertension (PH) at rest or with exertion that is responsible for limiting their activity level and impacting their quality of their life.
It is our goal in the proposed study to systematically characterize symptomatic and asymptomatic patients greater than six months after mitral valve surgery using clinical data, echocardiographic evaluation, laboratory assessment, and in some patients, invasive hemodynamic measurements. The investigators will screen asymptomatic and symptomatic patients with resting echocardiography and also with echocardiography during exercise, as many patients will exhibit exercise-induced PH following mitral valve surgery. Pulmonary artery (PA) pressure will be estimated from echocardiography using Doppler-derived calculations. If elevated PA pressures are observed with echocardiography, then symptomatic patients will undergo right heart catheterization for invasive pressure measurement, which is the gold-standard for the diagnosis of PH. When PH is present and there is a normal wedge pressure (PCWP) during invasive pressure measurement, further assessment to identify potential candidates for PH therapy will be performed. This involves having patients breathe inhaled nitric oxide, a rapid-acting, pulmonary vasodilator with a short half-life. While breathing inhaled nitric oxide, blood pressure, PA pressure, PCWP, and cardiac output will be monitored to characterize individuals who could benefit symptomatically from pharmacotherapy to treat underlying PH. It is important to note that only a small minority of patients exhibit a positive vasodilator response and those with PH and a normal PCWP without an initial vasodilator response would still be identified as candidates for chronic PH therapy.
The information generated from this proposed research will make a significant contribution to the understanding of PH in a group of patients in whom it has not been previously studied. Scientific reports on the evaluation of patients with PH after mitral valve surgery are almost nonexistent from the modern era. Furthermore, patients with PH due to mitral valve disease have been excluded from clinical trials of agents currently approved by the U.S. Food and Drug Administration (FDA) to treat PH. Therefore, this work will carefully characterize PA pressures in an objective manner in a group of patients following mitral valve surgery who remain limited with respect to their activity levels. In addition, the investigators will gain a better understanding of the frequency with which patients have PH and a normal PCWP, which identifies a cohort of patients who could have an improvement in their symptoms and quality of life with chronic vasodilator treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic | – | –No dyspnea with exertion greater than 6 months after mitral valve surgery [New York Heart Association (NYHA) Functional Class I] |
| Symptomatic | – | –Dyspnea with exertion greater than 6 months after mitral valve surgery [New York Heart Association (NYHA) Functional Class II, III, or IV] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in the cardiology, pulmonary hypertension, or cardiac surgery clinics at the enrolling institutions
Key inclusion criteria (4 listed)
- Age > 18 years
- Greater than 6 months post-mechanical or bioprosthetic mitral valve replacement or mitral valve repair (quadrangular resection, triangular resection, sliding plasty, and/or annuloplasty) surgery
- Dyspnea at rest or with exertion (NYHA II, III, or IV) [Symptomatic Study Group]
- Asymptomatic control group meeting criteria 1 and 2 above
Key exclusion criteria (15 listed)
- Current or prior chronic vasodilator therapy for pulmonary hypertension
- Known collagen vascular disease
- HIV infection: Based on self-report /historical diagnosis
- Portal hypertension
- Prior anorexigen use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of pulmonary hypertension
Time frame: greater than 6 months after mitral valve surgery
study evaluation period will take several hours to complete the components of the study (clinical evaluation, echocardiogram, etc.) on approximately 2 occasions
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 May 2017.
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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.
Andrew Wang, M.D. principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Mitral Valve Disease, run by Duke University at 2 sites 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 4 inclusion and 15 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Prevalence of pulmonary hypertension (time frame: greater than 6 months after mitral valve surgery). 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 May 2017.