The Effect of Diet and Exercise in Heart Failure
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|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
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive Metabolic Syndrome X Obesity||Behavioral: Lifestyle Modification (diet, exercise, and behavior)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lifestyle Modification in the Treatment of Heart Failure|
|Study Start Date :||March 2005|
- Measuring the change in Flow Mediated Dilation (FMD) and flow velocity integral (FVI) to assess endothelial function.
- Correlating change in vascular reactivity with renin, angiotensin II, and aldosterone levels.
- Examining the impact of the lifestyle interventions on quality of life as measured by the validated Kansas City Cardiomyopathy Questionnaire.
- Assessing the effectiveness of the lifestyle intervention by sequential tracking of the weekly minutes of physical activity and body composition parameters. Overall exercise tolerance will be assessed using the 6 minute walk test.
- Defining alterations in metabolic syndrome parameters, inflammatory cytokines and platelet activation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297154
|Contact: Melissa Brock, RN||713-873-8772|
|Contact: Betsy Staudinger, RN||713-873-8772|
|United States, Texas|
|Ben Taub General Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Allison M. Pritchett, M.D.||Baylor College of Medicine|
|Principal Investigator:||Douglas L Mann, M.D.||Baylor College of Medicine|