IRB Number:

2288-03

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Research suggests that many cases of cardiomyopathy are caused initially by a virus, which then causes the body's immune system to attack the heart. This is an inflammatory
reaction which leads to heart damage. In some patients with this disorder, the heart will recover significantly over the first year, while others will be left with a chronically weak heart. The purpose of this research study is to determine if persons who present with the recent onset of primary cardiomyopathy have a better chance of recovery if they have certain genes and for a stronger inflammatory reaction.

Who is Eligible to Participate in the Study?

Men or women over the age of 18 who have been diagnosed with congestive heart failure may be eligible to participate in this research study.

What is Involved With this Study?

Upon study entry qualified participants will have 30-45 mls (2-3 tablespoons) of blood drawn. Participants will be asked to come back to the Mayo Clinic Rochester two times during the first year, at one month and again at six months after study entry.

At each of the one month and six month visits, an additional 10 mls (two teaspoons) of blood will be drawn to measure cytokines (proteins which act in generating an immune response). Each visit will last about one hour.

At the six month visit, an additional 10 mls of blood will be drawn and stored for the analysis of proteins and hormones which affect the progression of heart failure, and an echocardiogram will be done to measure the heart’s strength, with the use of sound waves.

After the six month visit, additional follow up will be done by telephone calls every six months for up to 4 years by a nurse or doctor to gather information on how the participant is doing.

How long will the Study run?

Participants will be enrolled in this research study for up to four years.

Who can I Contact for Additional Information on this Trial?

To participate or to obtain additional information please call (507) 284-3680.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 09/10/2004