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The Effect of Diet and Exercise in Heart Failure (LIMIT-HF)

Primary Purpose

Heart Failure, Congestive, Metabolic Syndrome X, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle Modification (diet, exercise, and behavior)
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Heart failure, congestive, Metabolic Syndrome X, Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must meet 3 or more of the NCEP defined criteria for metabolic syndrome Waist circumference greater than 40 inches (102 cm) for men and 35 inches ( 88 cm) for women Serum triglyceride level greater than or equal to 150 mg/dL HDL level less than 40 mg/dL for men or 50 mg/dL for women Blood pressure greater than 130/85 or treatment for hypertension Fasting glucose greater than 110 mg/dL or treatment for diabetes Individuals with heart failure of ischemic or nonischemic etiologies * NYHA class II - III symptoms Left ventricular ejection fraction less than 40% Age 18-75 years BMI greater than 25 kg/m2 Patients must have undergone a VO2 or exercise stress test within the last 6 months to exclude active ischemia or exercise-induced dysrhythmias Exclusion Criteria: NYHA IV or 6 minute walk less than 300 meters Blood pressure greater than 160/100 mmHg Patients undergoing active titration of their cardiac medications Other comorbid illnesses which limit expected lifespan or affect the safety of interventions Weight loss of more than 10 pounds of non-edematous body weight within the past 3 months Pregnancy HIV+, active tuberculosis or hepatitis C Cancer requiring treatment within the past 5 years, unless the prognosis is excellent Unstable angina, myocardial infarction, coronary artery bypass surgery, or angioplasty within the last 3 months Angina with exertion History of malignant arrythmias (Ventricular Tachycardia / Ventricular Fibrillation) without implanted defibrillator Valvular heart disease: Symptomatic aortic or mitral stenosis Asymptomatic aortic or mitral stenosis that is moderate or greater in severity Severe mitral regurgitation Hypertrophic cardiomyopathy Severe pulmonary hypertension with a pulmonary artery systolic pressure > 60 mmHg - Aortic aneurysm (>6 cm in diameter) Factors that may limit adherence to interventions or affect conduct of the trial Unable or unwilling to given informed consent Self-report of substance abuse within the past 12 months - Failure to comply with the run-in dietary intake and exercise period History of bariatric surgery Chronic treatment with corticosteroids Current diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder Current use of medications for weight loss Inability to walk two blocks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Lifestyle modification

    Arm Description

    Patients continue receive a single educational session and continue medical managment of heart failure as per their physician

    Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 27, 2006
    Last Updated
    February 28, 2020
    Sponsor
    Baylor College of Medicine
    Collaborators
    National Center for Research Resources (NCRR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00297154
    Brief Title
    The Effect of Diet and Exercise in Heart Failure
    Acronym
    LIMIT-HF
    Official Title
    Lifestyle Modification in the Treatment of Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baylor College of Medicine
    Collaborators
    National Center for Research Resources (NCRR)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Congestive, Metabolic Syndrome X, Obesity
    Keywords
    Heart failure, congestive, Metabolic Syndrome X, Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients continue receive a single educational session and continue medical managment of heart failure as per their physician
    Arm Title
    Lifestyle modification
    Arm Type
    Experimental
    Arm Description
    Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle Modification (diet, exercise, and behavior)
    Intervention Description
    Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program.
    Primary Outcome Measure Information:
    Title
    Measuring the change in Flow Mediated Dilation (FMD) and flow velocity integral (FVI) to assess endothelial function.
    Time Frame
    6 months
    Title
    Correlating change in vascular reactivity with renin, angiotensin II, and aldosterone levels.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Examining the impact of the lifestyle interventions on quality of life as measured by the validated Kansas City Cardiomyopathy Questionnaire.
    Time Frame
    3 and 6 months
    Title
    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.
    Time Frame
    3 and 6 months
    Title
    Defining alterations in metabolic syndrome parameters, inflammatory cytokines and platelet activation.
    Time Frame
    3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must meet 3 or more of the NCEP defined criteria for metabolic syndrome Waist circumference greater than 40 inches (102 cm) for men and 35 inches ( 88 cm) for women Serum triglyceride level greater than or equal to 150 mg/dL HDL level less than 40 mg/dL for men or 50 mg/dL for women Blood pressure greater than 130/85 or treatment for hypertension Fasting glucose greater than 110 mg/dL or treatment for diabetes Individuals with heart failure of ischemic or nonischemic etiologies * NYHA class II - III symptoms Left ventricular ejection fraction less than 40% Age 18-75 years BMI greater than 25 kg/m2 Patients must have undergone a VO2 or exercise stress test within the last 6 months to exclude active ischemia or exercise-induced dysrhythmias Exclusion Criteria: NYHA IV or 6 minute walk less than 300 meters Blood pressure greater than 160/100 mmHg Patients undergoing active titration of their cardiac medications Other comorbid illnesses which limit expected lifespan or affect the safety of interventions Weight loss of more than 10 pounds of non-edematous body weight within the past 3 months Pregnancy HIV+, active tuberculosis or hepatitis C Cancer requiring treatment within the past 5 years, unless the prognosis is excellent Unstable angina, myocardial infarction, coronary artery bypass surgery, or angioplasty within the last 3 months Angina with exertion History of malignant arrythmias (Ventricular Tachycardia / Ventricular Fibrillation) without implanted defibrillator Valvular heart disease: Symptomatic aortic or mitral stenosis Asymptomatic aortic or mitral stenosis that is moderate or greater in severity Severe mitral regurgitation Hypertrophic cardiomyopathy Severe pulmonary hypertension with a pulmonary artery systolic pressure > 60 mmHg - Aortic aneurysm (>6 cm in diameter) Factors that may limit adherence to interventions or affect conduct of the trial Unable or unwilling to given informed consent Self-report of substance abuse within the past 12 months - Failure to comply with the run-in dietary intake and exercise period History of bariatric surgery Chronic treatment with corticosteroids Current diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder Current use of medications for weight loss Inability to walk two blocks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allison M. Pritchett, M.D.
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Douglas L Mann, M.D.
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The Effect of Diet and Exercise in Heart Failure

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