Patients Suffering From Heart Failure Learn of Gene Therapy Clinical Trial Opportunity

Copyright (c) 2008 Katie Kelley

Researchers are beginning the second phase of a clinical trial that aims to relieve heart failure patients of their condition by using gene therapy.

Physicians at the New York-Presbyterian Hospital/Columbia University Medical Center are studying heart failure patients' reactions to gene therapy drugs in the study known as Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID).

According to results from Phase I of the study, which was conducted to determine safe dosage ranges and determine drug side effects, found that seven of the nine patients involved "showed improvements over six months."

Phase II of the study has expanded the number of patients involved as well as created a "randomized, double-blind, placebo-controlled clinical trial that will compare the therapy at two or three dose levels with a placebo," according to a Science Daily news article explaining the trial. Approximately 46 individuals are to enroll at 13 hospitals across the United States in Phase II.

What is Gene Therapy?

The National Library of Medicine (NLM) explains that gene therapy is "an experimental technique that uses genes to treat or prevent disease by inserting a gene into a patients cells instead of using drugs or surgery."

The NLM also reports that there are a variety of methods used in gene therapy including the following:

* Implementing a healthy gene copy as a replacement for a mutated gene.

* If a mutated gene is "improperly functioning" gene therapy can be administered by inactivating the gene.

* The administration of a new gene to assist the body in fighting the disease can be introduced.

Heart Failure Causes

According to the Science Daily news article there are approximately 5 million individuals currently living with heart failure and heart disease conditions that puts them at risk for severe injury or death each day. Additionally, the article reported that "heart failure is the only cardiovascular disease whose incidence has been increasing rather than decreasing in recent years."

There are a number of factors that are related to the development of heart disease or heart failure among patients. The following factors and conditions may assist in development of the disease, according to the American Heart Association (AHA). These factors can include:

* overactive thyroid glands

* abnormal heart rhythms

* severe anemia

* diabetes

* serious lung disease

* coronary artery disease

* myocardial infarction

* abnormal heart valves

* heart defects such as congenital heart disease

* heart muscle disease

* hypertension

Additionally, one of the newest causes for heart failure and heart disease is actually a man-made cause, which is the development of prescription drugs that pose a risk to one?s health.

Pharmaceutical Dangers

Of the pharmaceutical dangers that may increase the potential for an individual developing heart disease is that of Avandia. Avandia is a type 2 diabetes drug that was released in May 1999 from GlaxoSmithKline and had been prescribed to millions of diabetic patients.

Avandia, part of a newer class of medications, including Actos, was linked in a 2007 New England Journal of Medicine article to the development of heart failure among diabetic patients whose risk for developing the heart failure is increased because of their diabetic condition.

It may be necessary to find new medications if Avandia side effects occur among a type 2 diabetes patient. Additionally, speaking to a pharmaceutical attorney may provide the necessary legal assistance for an individual to obtain monetary compensation in regards to their suffering from dangerous Avandia risks.