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Geriatric Out of Hospital Randomized Meal Trial in Heart Failure (GOURMET-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02148679
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : July 27, 2017
Sponsor:
Collaborators:
PurFoods, LLC
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Scott L. Hummel, University of Michigan

Tracking Information
First Submitted Date  ICMJE May 23, 2014
First Posted Date  ICMJE May 28, 2014
Last Update Posted Date July 27, 2017
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date May 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL in patients with chronic HF [ Time Frame: from study enrollment to 4 weeks post-discharge ]
The KCCQ, a self-administered 23-item instrument, assesses physical limitations, symptoms, self-efficacy, social interference, and overall QOL in HF patients. The KCCQ summary score ranges from 0-100, with higher scores indicating better QOL. The KCCQ summary score independently predicts clinical outcomes such as hospitalization and mortality in outpatients with HF, including those recently hospitalized for acute decompensation. It is a reliable and valid measure in HF patients that is more sensitive to change than other measures of QOL, and is especially responsive in patients with multiple comorbidities. A change in KCCQ score of 5 points is clinically significant and correlates with changes in clinical status, physical function, and outcomes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
  • Safety Monitoring [ Time Frame: Baseline and 1 week post discharge ]
    Renal function and electrolytes will be assessed at baseline and 1 week post-discharge during a safety visit, in which vital signs and targeted physical examination for volume status will allow adjustment of diuretics as clinically indicated. The dietary intervention will be stopped in any patient who develops new or worsened renal impairment as defined by estimated glomerular filtration rate decrease of ≥50%, hyperkalemia (K >5.7 mmol/L), syncope, or other serious adverse event deemed by the investigators to be related to study participation (note participants are inherently at high risk for rehospitalization or mortality, ~20-25% over the 4-week intervention period of the study, ~30-35% over the total 12-week term of the study). Patients randomized to food delivery will have study food intake suspended if hospitalized and resumed at discharge if no safety concerns as defined above.
  • Dietary Endpoints [ Time Frame: baseline, 4 weeks ]
    Dietary endpoints will include DASH/SRD adherence as measured by 3-day food diary and urinary electrolyte measures (24-hour urinary sodium and potassium). Food frequency questionnaire to establish baseline dietary intake will be obtained at baseline and 12 weeks.
  • Mechanism-related endpoints [ Time Frame: Baseline to 4 weeks ]
    Mechanism-related endpoints will include changes from baseline to 4 weeks in clinic and 24-hour blood pressure, noninvasive measures of ventricular function and ventricular-arterial coupling, blood/urine measures of neurohormonal activation, oxidative stress, and systemic inflammation, blood volume measurements (subset n=20), and peripheral blood mononuclear cell (PBMC) RNA profiling (subset n=20)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Geriatric Out of Hospital Randomized Meal Trial in Heart Failure
Official Title  ICMJE Effects of Home-delivered Low-sodium Meals in Older Adults Following Heart Failure Hospitalization.
Brief Summary Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge.
Detailed Description

This is a three center, randomized, single-blind, attention controlled trial of 12 weeks total duration designed to determine the safety and efficacy of home-delivered sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD)-compliant meals in older adults (age >= 65 years) following discharge from a hospital admission for acutely decompensated heart failure. 66 subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (< vs. ≥ 50%).

107 subjects yielded 66 randomized subjects.

Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge. The three study sites will be Columbia University Medical Center, the Ann Arbor Veterans Affairs Health System, and the University of Michigan Health System. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until the completion of the study

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Other: DASH/SRD
    Study food for this investigation will be designed and prepared by PurFoods, LLC (Des Moines, IA) dietitians under the direction of Dr. Sam Beattie, Ph. D., and in consultation with research dietitians at the University of Michigan and Columbia University. Study patients randomized to food delivery will select from an available menu of meal options that adhere to nutritional targets as above. Study food will be pre-packaged for storage with preparation (typically microwave heating) to be completed at home by the subject, and will be delivered every 1 to 2 weeks under the direction of PurFoods.
    Other Name: Mom's Meals
  • Other: Usual care
    Standardized advice to restrict dietary sodium intake to < 2000 mg/day
Study Arms  ICMJE
  • Experimental: DASH/SRD

    Patients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge

    Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions

    Intervention: pre-prepared, home delivered DASH/SRD-compliant meals for 4 weeks after hospital discharge

    Intervention: Other: DASH/SRD
  • Placebo Comparator: Attention Control

    Patients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge

    Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions

    Interventions:
    • Other: DASH/SRD
    • Other: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
107
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2014)
60
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date May 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

66 male and female patients aged ≥ 55 years with history of systemic hypertension and acutely decompensated heart failure (ADHF; primary diagnosis for admission or secondary diagnosis after hospitalization for another reason). ADHF will be confirmed by the study physician and defined as a combination of symptoms, signs, and HF-specific medical treatments. Specifically, ADHF will require that all four of the following conditions are met:

  • ≥1 symptom of HF (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea) has worsened from baseline
  • ≥ 2 signs of HF (pulmonary congestion on exam and/or chest X-ray, elevated jugular venous pressure, peripheral edema or rapid weight gain, and/or increased B-type natriuretic peptide (BNP; ≥100 pg/ml)
  • change in medical treatment specifically targeting HF (diuretics, vasodilators, and/or neurohormonal modulating agents)
  • no other cause of the patient's symptoms and signs is apparent

Exclusion Criteria:

  • persistent hypotension during hospitalization or excessive risk of hypotension from the study diet as judged by the investigators or systolic BP <110 on discharge
  • use of inotropic therapy at hospital discharge,
  • severe valvular heart disease as the primary etiology of the patient's HF syndrome
  • uncontrolled hypertension defined as the following criteria for the last 24 hours prior to discharge (systolic BP >180 mmHg or diastolic BP >100 mmHg)
  • having two or more results of a serum potassium >5.0 mmol/L during hospitalization or history of serum potassium >6.0 mmol/L, and/or at an excessive risk of hyperkalemia as judged by the investigators
  • severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m^2 at discharge)
  • severe anemia (hemoglobin < 9 gm/dl)
  • length of stay <48 hours or >14 days
  • co-morbidity with expected survival < 12 months
  • active alcohol or substance abuse
  • history of persistent noncompliance with treatment recommendations as judged by the investigators
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: eligibility is based on self-representation of gender identity.
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02148679
Other Study ID Numbers  ICMJE HUM00083272
R21AG047939 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott L. Hummel, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE
  • PurFoods, LLC
  • National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Scott L Hummel, MD, MS University of Michigan
PRS Account University of Michigan
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP