The Effect of Diet and Exercise in Heart Failure
|ClinicalTrials.gov Identifier: NCT00297154|
Recruitment Status : Unknown
Verified December 2010 by Baylor College of Medicine.
Recruitment status was: Recruiting
First Posted : February 28, 2006
Last Update Posted : December 6, 2010
|First Submitted Date ICMJE||February 27, 2006|
|First Posted Date ICMJE||February 28, 2006|
|Last Update Posted Date||December 6, 2010|
|Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00297154 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effect of Diet and Exercise in Heart Failure|
|Official Title ICMJE||Lifestyle Modification in the Treatment of Heart Failure|
A growing number of people in this country are overweight or obese. This is concerning as increasing weight has been shown to increase the risk of developing heart failure. However, there is also research to suggest that in people who already have heart failure, heavier people live longer. So, how does being overweight put a person at risk for heart failure, but once they have heart failure, protect them? There is no clear explanation for this dilemma.
People who are obese commonly have other diseases, such as high blood pressure, high cholesterol, and diabetes, that increase the risk of developing heart disease. It is this group of diseases that is referred to as "The Metabolic Syndrome." People with the metabolic syndrome also have increased levels of inflammation and clotting proteins in their blood stream. Current treatment of the metabolic syndrome involves using medications for cholesterol, blood pressure, and diabetes. Diet and exercise are also commonly recommended.
"Lifestyle intervention programs" are programs that help people lose weight by changing their eating habits and exercise / activity routines. Weight loss and exercise have been shown to lower the risk of developing diabetes and improve diabetes control, improve cholesterol abnormalities, and lower blood pressure. These programs have not previously included heart failure patients, however.
We hypothesize that using a lifestyle intervention program in addition to the usual medications for heart failure will result in improved symptoms of heart failure and control of the metabolic syndrome.
This study will be the first research study to look at the use of diet and exercise in treating heart failure patients who are overweight / obese with "the metabolic syndrome." The study will last 6 months. From this study we hope to learn whether diet and exercise is helpful in treating heart failure patients who are overweight. Specifically, the study will look at the short term effects on cardiac risk factors (blood pressure, cholesterol, blood sugar), heart failure symptoms, and exercise capacity.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Lifestyle Modification (diet, exercise, and behavior)|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||60|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 75 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00297154|
|Other Study ID Numbers ICMJE||H-16557|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Baylor College of Medicine|
|Collaborators ICMJE||National Institutes of Health (NIH)|
|PRS Account||Baylor College of Medicine|
|Verification Date||December 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP