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The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle modification program on symptoms and signs of heart failure as well as laboratory and echocardiographic measures of cardiac structure and function. This will be a 6 month trial in 50 patients with a clinical diagnosis of heart failure with preserved ejection fraction (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight management 15 week lifestyle change program which will involve weekly visits that rotate among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with the research Registered Nurse. Each patients baseline data will be used as the control and compared with the same measurements at the 6 month end point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle modification | Experimental | Lifestyle modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle modification | Dietary Supplement | Subjects will be given meal replacements (shakes and bars) to be consumed twice per day for 8 weeks, and then once per day for an additional 3 weeks, and then transitioned to a structured diet. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 minute hall walk test from baseline | Exercise capacity | 6 months |
| Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores | Quality of life assessment specific for congestive heart failure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular mass | Changes in left ventricular mass will be measured by transthoracic echocardiography | 6 months |
| Brain Natriuretic Peptide | Brain natriuretic peptide will be measured in serum using standard commercial assay |
| Measure | Description | Time Frame |
|---|---|---|
| Left Atrial Volume | Left atrial volume will be measured by transthoracic echocardiography | 6 months |
| Early mitral inflow velocity/mitral annular velocity (E/e') | E/e' will be measured by transthoracic echocardiography |
Inclusion Criteria:
Major:
Minor:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC Gazes Research Institue | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34713711 | Derived | El Hajj EC, El Hajj MC, Sykes B, Lamicq M, Zile MR, Malcolm R, O'Neil PM, Litwin SE. Pragmatic Weight Management Program for Patients With Obesity and Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Nov 2;10(21):e022930. doi: 10.1161/JAHA.121.022930. Epub 2021 Oct 29. |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001836 | Body Weight Changes |
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| 6 months |
| 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |