AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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.

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 groups in NCT01646541
Study groupRoleWhat they receive
AsymptomaticNo dyspnea with exertion greater than 6 months after mitral valve surgery [New York Heart Association (NYHA) Functional Class I]
SymptomaticDyspnea 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.

  1. 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.

  1. First posted20 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in