Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure

For a majority of patients with advanced heart failure, medical treatment is only partially
effective in relieving heart failure symptoms. Therefore, it is recommended that palliative
care be initiated soon after diagnosis. There is a need for complementary, nonpharmacologic
interventions that could be easily implemented by health care providers to provide
palliative care. Three major pathologic pathways underlying heart failure symptoms have been
identified: fluid overload, inflammation, and oxidative stress. Prior research has
demonstrated that three nutrients-sodium, omega-3 fatty acids, and lycopene-can alter these
pathologic pathways. Clinical trials to date have only tested each nutrient individually.
There is strong theoretical rationale that a combined intervention targeting all three
nutrients would have substantial benefit in relieving symptoms in advanced heart failure.
Therefore, the purposes of this study are to test the effects of a 6-month nutrition
intervention of dietary sodium reduction combined with supplementation of lycopene and
omega-3 fatty acids on heart failure symptoms, health-related quality of life, and time to
heart failure rehospitalization or all-cause death. The aims of this placebo controlled
study are 1) to determine the effects of a 6-month nutrition intervention on symptom burden
(edema, shortness of air, and fatigue) and health related quality of life at 3 and 6 months,
and time to heart failure rehospitalization or all-cause death over 12 months from baseline;
2) compare dietary sodium intake, inflammation, and markers of oxidative stress between the
nutrition intervention group and a placebo group at 3 and 6 months; and 3) compare body
weight, serum lycopene, and erythrocyte omega-3 index between the nutrition intervention
group and a placebo group at 3 and 6 months. A total of 150 patients with advanced heart
failure will be randomized to either the nutrition intervention or placebo group (75 per
group). The nutrition intervention group will receive a theory based education and skill
building intervention designed to decrease dietary sodium intake to ~2 g per day. A research
nurse will make 4 home visits and one follow-up telephone call over 6 months to provide the
education-skill building intervention. The intervention group will take 3 omega-3 fatty acid
capsules (350 mg eicosapentaenoic acid and 50 mg docosahexaenoic acid) and consume tomato
juice or other tomato-based products containing 20-25 mg of lycopene daily for six months.
The placebo group will receive the same number of visits and phone calls but only general
nutrition information will be provided. They will take 3 placebo capsules containing rice
oil (500 mg/capsule) and consume their choice of fruit juices that do not contain lycopene
daily for six months. Data will be collected in person at baseline, 3 months, and 6 months
by a research assistant blinded to the group assignment. Patients will be followed for an
additional 6 months by telephone to collect longer term data on symptom burden and quality
of life as well as heart failure hospitalization and all-cause mortality at 9 and 12 months.

Inclusion Criteria:

- chronic heart failure with either preserved or non-preserved ejection fraction

- for chronic heart failure, have undergone evaluation of heart failure and
optimization of medical therapy, for patients discharged from hospital for
acute/newly diagnosed heart failure, have undergone evaluation of heart failure and
optimization of medical therapy for at least 1 month post discharge

- New York Heart Association functional classification of II, III or IV

- have not been referred for heart transplantation

- able to read and speak English

- no cognitive impairment that precludes giving informed consent or ability to follow
protocol instruction.

Exclusion Criteria:

- BMI < 17 kg/m2 or > 46 kg/m2

- co-existing illness documented in the medical record known to be associated with
systemic inflammation decreased appetite or absorption, fatigue, edema, or weight
loss

- currently taking dietary supplements that contain lycopene or omega-3 fatty acids

- allergy to rice bran oil