Featured Research

from universities, journals, and other organizations

More Patients Needed In Clinical Trials To Find Treatment For Heart Condition

May 11, 2009
American Heart Association
Patent foramen ovale (PFO), an opening between the two chambers of the heart, has been associated with some strokes for which there has been no identifiable cause. Due to a lack of solid research and clinical evidence, there is no established ideal way to treat PFO. This statement identifies a number of ongoing trials for PFO and calls for doctors to enroll appropriate patients in these trials that could one day lead to a definitive treatment for this condition.

The American Heart Association and the American College of Cardiology are calling on doctors to enroll more patients in clinical trials for catheter-based closure of patent foramen ovale (PFO), a condition caused when an opening between the two chambers of the heart fails to close at birth. Due to a lack of conclusive research on the management of PFO after stroke or transient ischemic attack, there is currently no clearly established treatment for this condition.

Related Articles

This “call to action” advisory is published in Circulation: Journal of the American Heart Association and the Journal of the American College of Cardiology. The American Academy of Neurology has affirmed the value of this science advisory.

The advisory writing group notes there are a number of ongoing clinical trials looking at patients with PFO and cryptogenic strokes, which are strokes with no identifiable cause after an extensive search.

Enrollment in the trials has lagged and the off-label use of PFO closure devices has accelerated, jeopardizing the funding of some studies and the scientific validity of others. “Off-label” indicates when a device or drug is used to treat a condition not listed on its label. This is a common practice, especially for older drugs or devices that perhaps have found new uses but not been put through the rigors of FDA testing and approval for the new use.

“We must have enough patients followed for an adequate time in these trials to make the data valid and the findings strong,” said Patrick O’Gara, M.D., chair of the writing group and director of Clinical Cardiology at Brigham and Women’s Hospital in Boston. “The completion and peer review of these trials are critical to establishing the evidence base needed to help us make informed decisions regarding the best care for patients with this condition.”

Potential treatments for PFO are important for reducing stroke risk. The advisory cites research that shows PFO present in 33.8 percent to 43.9 percent of patients with cryptogenic stroke. A PFO is usually detected by echocardiography during evaluations after a stroke.

Although “optimal” treatment for PFO isn’t established, current options for treatment include drug therapy with either anti-platelet agents like aspirin or vitamin K antagonists such as warfarin, surgical repair, or closing the opening with catheter-based (percutaneous) devices. Surgical repair is not usually recommended unless a patient is already undergoing surgery for another reason.

Current American Heart Association/American Stroke Association guidelines recommend anti-platelet medication as the first-line therapy for PFO. Warfarin should be considered if there is an additional indication for anticoagulation. They say that there isn’t enough evidence to recommend closing a PFO after a first stroke, but that closure may be considered for patients with recurrent cryptogenic stroke despite optimal medical therapy.

The choice between drug therapy and catheter-based repair has been intensely debated. To date, adequately powered, randomized, prospective clinical trials comparing drug therapy with catheter-based repair have yet to be completed.

Three Food and Drug Administration (FDA) advisory committee meetings (1997, 2002 & 2007) have affirmed the need for completing appropriately sized randomized controlled clinical trials to compare drug therapy with percutaneous device closure. As yet, no device for PFO closure is approved by the FDA.

In addition to the call for doctors to refer more patients to the ongoing trials, the advisory group recommends the data from these trials should be pooled where appropriate and that the “off-label” use of closure devices should be curtailed.

Co-authors include Gloria Catha, Steven R. Messe, M.D.; John C. Ring and E. Murat Tuzcu, M.D.

Story Source:

The above story is based on materials provided by American Heart Association. Note: Materials may be edited for content and length.

Cite This Page:

American Heart Association. "More Patients Needed In Clinical Trials To Find Treatment For Heart Condition." ScienceDaily. ScienceDaily, 11 May 2009. <www.sciencedaily.com/releases/2009/05/090511140949.htm>.
American Heart Association. (2009, May 11). More Patients Needed In Clinical Trials To Find Treatment For Heart Condition. ScienceDaily. Retrieved October 25, 2014 from www.sciencedaily.com/releases/2009/05/090511140949.htm
American Heart Association. "More Patients Needed In Clinical Trials To Find Treatment For Heart Condition." ScienceDaily. www.sciencedaily.com/releases/2009/05/090511140949.htm (accessed October 25, 2014).

Share This

More Mind & Brain News

Saturday, October 25, 2014

Featured Research

from universities, journals, and other organizations

Featured Videos

from AP, Reuters, AFP, and other news services

Academic Scandal Shocks UNC

Academic Scandal Shocks UNC

AP (Oct. 23, 2014) A scandal involving bogus classes and inflated grades at the University of North Carolina was bigger than previously reported, a new investigation found. (Oct. 23) Video provided by AP
Powered by NewsLook.com
Working Mother Getaway: Beaches Turks & Caicos

Working Mother Getaway: Beaches Turks & Caicos

Working Mother (Oct. 22, 2014) Feast your eyes on this gorgeous family-friendly resort. Video provided by Working Mother
Powered by NewsLook.com
What Your Favorite Color Says About You

What Your Favorite Color Says About You

Buzz60 (Oct. 22, 2014) We all have one color we love to wear, and believe it or not, your color preference may reveal some of your character traits. In celebration of National Color Day, Krystin Goodwin (@kyrstingoodwin) highlights what your favorite colors may say about you. Video provided by Buzz60
Powered by NewsLook.com
First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

Newsy (Oct. 21, 2014) A medical team has for the first time given a man the ability to walk again after transplanting cells from his brain onto his severed spinal cord. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.


Breaking News:

Strange & Offbeat Stories

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News


Free Subscriptions

Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile

Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?

Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins