Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure (NIHFT)

This study is currently recruiting participants.
Verified August 2013 by University of Kentucky
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Terry Lennie, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01733017
First received: November 15, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Behavioral: Sodium reduction
Dietary Supplement: omega 3 and lycopene supplements
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Nutrition Intervention to Reduce Symptoms in Patients With Advanced Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Event-Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Combined endpoint of cardiac-related hospitalization and all cause mortality

  • Symptom burden [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    combined score of symptom severity, frequency, and distress for common symptoms of heart failure

  • Quality of life [ Time Frame: baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    heart failure related quality of life


Secondary Outcome Measures:
  • omega-3 index [ Time Frame: baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    the ratio of EPA plus DHA as a percentage of total fatty acids in the cell membrane of erythrocytes

  • oxidative stress [ Time Frame: baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    serum levels of malondialdehyde and 8-iso-PGF2a isoprostane will serve as markers of increased lipid peroxidation due to oxygen free radical production exceeding antioxidant capacity

  • Inflammation [ Time Frame: baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Serum levels of tumor necrosis factor-alpha (TNFα), soluble TNF receptors: sTNFR1 and sTNFR2 will be measured as markers of proinflammatory cytokine activity; interleukin-10 (IL-10) will be measured as a marker of anti-inflammatory cytokine activity

  • Lycopene [ Time Frame: baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Plasma lycopene will be measured as a marker intervention effectiveness

  • Sodium intake [ Time Frame: baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Three 24-hour diet recall interviews at each timepoint will be used estimate sodium intake and to identify high sodium foods and eating patterns for the sodium reduction component of the intervention.


Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sodium reduction, omega-3, lycopene
combination of dietary sodium restriction with supplementation of omega-3 capsules and lycopene containing juices or foods
Behavioral: Sodium reduction
Teaching and skill building to reduce dietary sodium
Dietary Supplement: omega 3 and lycopene supplements
omega-3 fatty acid supplements and juices containing lycopene
Placebo Comparator: Control
Limited nutritional counseling, juice without lycopene, rice oil capsules

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733017

Contacts
Contact: Jeanine Veezie 800-896-8066 jdvezi2@email.uky.edu

Locations
United States, Kentucky
University of Kentucky, College of Nursing Recruiting
Lexington, Kentucky, United States, 40536-0232
Principal Investigator: Terry A Lennie, PhD         
Sponsors and Collaborators
University of Kentucky
Ohio State University
Investigators
Principal Investigator: Terry A Lennie, PhD University of Kentucky College of Nursing
  More Information

No publications provided

Responsible Party: Terry Lennie, PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT01733017     History of Changes
Other Study ID Numbers: RO1NR013430
Study First Received: November 15, 2012
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
heart failure
nutrition therapy
symptoms
quality of life
lycopene
omega-3 fatty acids

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014