Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT01733017
Run by: Terry Lennie
People needed: 150
Starts: 2011-11-01
Expected to finish: 2017-01-01
Last updated by the study team: 2017-03-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

University of Kentucky, College of Nursing — Lexington, Kentucky, United States
Norton Health Care — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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