Clinical trial NCT01733017: Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure
Official title: Nutrition Intervention to Reduce Symptoms in Patients With Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: heart failure
nutrition therapy
symptoms
quality of life
lycopene
omega-3 fatty acids
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2012-11-26
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of is 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Event-Free Survival
timeFrame: 12 months
measure: Symptom burden
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Quality of life
timeFrame: baseline, 3, 6, 9, 12 months
Secondary outcomes:
measure: omega-3 index
timeFrame: baseline, 3, 6, 9, 12 months
measure: oxidative stress
timeFrame: baseline, 3, 6, 9, 12 months
measure: Inflammation
timeFrame: baseline, 3, 6, 9, 12 months
measure: Lycopene
timeFrame: baseline, 3, 6, 9, 12 months
measure: Sodium intake
timeFrame: baseline, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky, College of Nursing
state: Kentucky
city: Louisville
country: United States
facility: Norton Health Care
state: Kentucky
Study officials:
affiliation: University of Kentucky College of Nursing
name: Terry A Lennie, PhD
role: PRINCIPAL_INVESTIGATOR
References: