Featured Research

from universities, journals, and other organizations

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

Date:
May 11, 2009
Source:
American Heart Association
Summary:
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.

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 August 2, 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 August 2, 2014).

Share This




More Mind & Brain News

Saturday, August 2, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Work Can Be Stressful, But Is Unemployment Worse?

Work Can Be Stressful, But Is Unemployment Worse?

Newsy (Aug. 1, 2014) A new study shows stress at work can be hard on your health, but people who are unemployed might be at even greater risk of health problems. Video provided by Newsy
Powered by NewsLook.com
Google (Kind Of) Complies With 'Right To Be Forgotten Law'

Google (Kind Of) Complies With 'Right To Be Forgotten Law'

Newsy (July 31, 2014) Google says it is following Europe's new "Right To Be Forgotten Law," which eliminates user information upon request, but only to a certain degree. Video provided by Newsy
Powered by NewsLook.com
Stroke Signs: Three Hour Deadline

Stroke Signs: Three Hour Deadline

Ivanhoe (July 31, 2014) Sometimes the signs of a stroke are far from easy to recognize. Learn from one young father’s story on the signs of a stroke. Video provided by Ivanhoe
Powered by NewsLook.com
Grain Brain May Be Harming Us

Grain Brain May Be Harming Us

Ivanhoe (July 31, 2014) Could eating carbohydrates be harmful to our brain health? Find out what one neurologist says about changing our diets. Video provided by Ivanhoe
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.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

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