Heart Failure, CongestiveLIMIT-HFNCT00297154
The Effect of Diet and Exercise in Heart Failure
A study testing Lifestyle Modification (diet, exercise, and behavior) in people with Heart Failure, Congestive and Metabolic Syndrome X, run by Baylor College of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Congestive, Metabolic Syndrome X, Obesity
- What is being tested?
- Lifestyle Modification (diet, exercise, and behavior)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
About this study
Official title: 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.
Read more
"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.
- Conditions
- Heart Failure, Congestive, Metabolic Syndrome X, Obesity
- Being tested
- Lifestyle Modification (diet, exercise, and behavior)
- Keywords
- Heart failure, congestive, Metabolic Syndrome X, Obesity
- Medical subject headings
- Heart Failure, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Modification (diet, exercise, and behavior)Behavioural
Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients continue receive a single educational session and continue medical managment of heart failure as per their physician |
| Lifestyle modification | Experimental | Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program. Receives: Behavioral: Lifestyle Modification (diet, exercise, and behavior) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the change in Flow Mediated Dilation (FMD) and flow velocity integral (FVI) to assess endothelial function.
Measured: 6 months
Correlating change in vascular reactivity with renin, angiotensin II, and aldosterone levels.
Measured: 6 months
Secondary outcomes (3)
Examining the impact of the lifestyle interventions on quality of life as measured by the validated Kansas City Cardiomyopathy Questionnaire.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
Defining alterations in metabolic syndrome parameters, inflammatory cytokines and platelet activation.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startMar 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Allison Pritchett, Baylor College of Medicine
- Investigators
- Allison M. Pritchett, M.D., Principal investigator, Baylor College of MedicineDouglas L Mann, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297154
- Sponsor's protocol ID
- H-16557
- Other IDs
- K12RR017665
- Acronym
- LIMIT-HF
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2006
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Modification in the Treatment of Heart Failure
- ClinicalTrials.gov ID
- NCT00297154
- Acronym / sponsor ID
- LIMIT-HF / H-16557
- Conditions
- Heart Failure, Congestive, Metabolic Syndrome X, Obesity
- Keywords
- Heart failure, congestive, Metabolic Syndrome X, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Mar 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients continue receive a single educational session and continue medical managment of heart failure as per their physician |
| Lifestyle modification | Experimental | Behavioral: Lifestyle Modification (diet, exercise, and behavior)Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must meet 3 or more of the NCEP defined criteria for metabolic syndrome
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Modification (diet, exercise, and behavior)Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program. | Behavioural | Lifestyle modification |
Primary outcome
Measuring the change in Flow Mediated Dilation (FMD) and flow velocity integral (FVI) to assess endothelial function.
Time frame: 6 months
Correlating change in vascular reactivity with renin, angiotensin II, and aldosterone levels.
Time frame: 6 months
3 secondary outcomes
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
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
Defining alterations in metabolic syndrome parameters, inflammatory cytokines and platelet activation.
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison M. Pritchett, M.D. principal investigator
Baylor College of Medicine
Douglas L Mann, M.D. principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification (diet, exercise, and behavior) in people with Heart Failure, Congestive and Metabolic Syndrome X, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the change in Flow Mediated Dilation (FMD) and flow velocity integral (FVI) to assess endothelial function. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.