Effects of a High Protein Diet on Clinical Outcomes in Heart Failure

Clinical management of heart failure (HF) related to obesity and diet recommendations
currently lacks a strong scientific basis, and clinicians are divided in their approach to
diet recommendations for this patient population. It has been shown that in extremely obese
HF patients, weight reduction improves cardiac structure and function as well as functional
status and symptomatology. Evidence on the impact of voluntary weight loss on improvement
in survival in obese HF patients, however, is limited.

The purpose of this study is to determine whether or not heart failure patients
participating in a 3-month intensive lifestyle modification program of either a high protein
(30% of total calories from protein) group will have a significant improvement in weight
reduction, quality of life and clinical outcomes compared to a standardized protein (15% of
total calories from protein) group.

In addition to dietary interventions, participants in both groups with be given an exercise
prescription and encouraged to exercise for 20-30 minutes at least 3-5 times each week as
tolerated. They will also continue to receive usual medical care, advice and other support
for their condition from their cardiologist or medical physician. Both sets of participants
will utilize self-monitoring tools to assist with diet compliance and behavior change. These
self-monitoring tools are mandatory and will be collected and analyzed. At each visit,
subjects will also be asked to will also be asked to have their weight and waist
circumference measured and, at select visits, they will provide a 24 hour recall to assess
fullness with the overall diet. Subjects will be given a 3-day food (3DFR) record at
baseline, which will be returned at the the 2-week, 4- week and 8-week visits, and will
also complete the 3DFR at three months.

Inclusion Criteria:

- obese (BMI > 27 kg/m2);

- history of type 2 DM or documented impaired fasting glucose (IFG) according to
fasting plasma glucose levels of 100-125 mg/dl or meeting 3 out of 4 criteria or
Metabolic Syndrome ( as defined by the International Diabetes Federation 2011

- evaluation of HF and optimization of medical therapy; and

- ischemic or idiopathic HF etiology.

Exclusion Criteria:

- age ≤18 years old;

- history of clinically significant illness including acute myocardial infarction or
sustained ventricular arrhythmia in the prior 3 months or current liver, respiratory,
and/or gastrointestinal disease and malignancy;

- pregnancy or lactation;

- serum creatinine level > 1.5 mg/dl;*

- currently participating in a supervised weight loss program;

- physician refusal to permit patient participation in the study; and

- weight loss of >6% in the last 6 months

- gout or history of gout