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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DASH/SRD

Usual care

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Diet

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ann Arbor Veterans Affairs Health System
University of Michigan
Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DASH/SRD

Attention Control

Arm Description

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

Outcomes

Primary Outcome Measures

change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL in patients with chronic HF

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.

Secondary Outcome Measures

Safety Monitoring

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

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

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)

Full Information

NCT ID

NCT02148679

First Posted

May 23, 2014

Last Updated

July 25, 2017

Sponsor

University of Michigan

Collaborators

PurFoods, LLC, National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT02148679

Brief Title

Geriatric Out of Hospital Randomized Meal Trial in Heart Failure

Acronym

GOURMET-HF

Official Title

Effects of Home-delivered Low-sodium Meals in Older Adults Following Heart Failure Hospitalization.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

May 21, 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

PurFoods, LLC, National Institute on Aging (NIA)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Heart Failure, Diet

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DASH/SRD

Arm Type

Experimental

Arm Description

Arm Title

Attention Control

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

DASH/SRD

Other Intervention Name(s)

Mom's Meals

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

Standardized advice to restrict dietary sodium intake to < 2000 mg/day

Primary Outcome Measure Information:

Title

change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL in patients with chronic HF

Description

Time Frame

from study enrollment to 4 weeks post-discharge

Secondary Outcome Measure Information:

Title

Safety Monitoring

Description

Time Frame

Baseline and 1 week post discharge

Title

Dietary Endpoints

Description

Time Frame

baseline, 4 weeks

Title

Mechanism-related endpoints

Description

Time Frame

Baseline to 4 weeks

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

eligibility is based on self-representation of gender identity.

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott L Hummel, MD, MS

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ann Arbor Veterans Affairs Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19854331

Citation

Hummel SL, DeFranco AC, Skorcz S, Montoye CK, Koelling TM. Recommendation of low-salt diet and short-term outcomes in heart failure with preserved systolic function. Am J Med. 2009 Nov;122(11):1029-36. doi: 10.1016/j.amjmed.2009.04.025.

Results Reference

background

PubMed Identifier

23033371

Citation

Hummel SL, Seymour EM, Brook RD, Kolias TJ, Sheth SS, Rosenblum HR, Wells JM, Weder AB. Low-sodium dietary approaches to stop hypertension diet reduces blood pressure, arterial stiffness, and oxidative stress in hypertensive heart failure with preserved ejection fraction. Hypertension. 2012 Nov;60(5):1200-6. doi: 10.1161/HYPERTENSIONAHA.112.202705. Epub 2012 Oct 1.

Results Reference

background

PubMed Identifier

23985432

Citation

Hummel SL, Seymour EM, Brook RD, Sheth SS, Ghosh E, Zhu S, Weder AB, Kovacs SJ, Kolias TJ. Low-sodium DASH diet improves diastolic function and ventricular-arterial coupling in hypertensive heart failure with preserved ejection fraction. Circ Heart Fail. 2013 Nov;6(6):1165-71. doi: 10.1161/CIRCHEARTFAILURE.113.000481. Epub 2013 Aug 28.

Results Reference

background

PubMed Identifier

15246908

Citation

Bray GA, Vollmer WM, Sacks FM, Obarzanek E, Svetkey LP, Appel LJ; DASH Collaborative Research Group. A further subgroup analysis of the effects of the DASH diet and three dietary sodium levels on blood pressure: results of the DASH-Sodium Trial. Am J Cardiol. 2004 Jul 15;94(2):222-7. doi: 10.1016/j.amjcard.2004.03.070. Erratum In: Am J Cardiol. 2010 Feb 15;105(4):579.

Results Reference

background

PubMed Identifier

20200258

Citation

Troyer JL, Racine EF, Ngugi GW, McAuley WJ. The effect of home-delivered Dietary Approach to Stop Hypertension (DASH) meals on the diets of older adults with cardiovascular disease. Am J Clin Nutr. 2010 May;91(5):1204-12. doi: 10.3945/ajcn.2009.28780. Epub 2010 Mar 3.

Results Reference

background

PubMed Identifier

23102175

Citation

Racine EF, Lyerly J, Troyer JL, Warren-Findlow J, McAuley WJ. The influence of home-delivered dietary approaches to stop hypertension meals on body mass index, energy intake, and percent of energy needs consumed among older adults with hypertension and/or hyperlipidemia. J Acad Nutr Diet. 2012 Nov;112(11):1755-62. doi: 10.1016/j.jand.2012.06.358.

Results Reference

background

PubMed Identifier

25728723

Citation

Wessler JD, Maurer MS, Hummel SL. Evaluating the safety and efficacy of sodium-restricted/Dietary Approaches to Stop Hypertension diet after acute decompensated heart failure hospitalization: design and rationale for the Geriatric OUt of hospital Randomized MEal Trial in Heart Failure (GOURMET-HF). Am Heart J. 2015 Mar;169(3):342-348.e4. doi: 10.1016/j.ahj.2014.11.021. Epub 2015 Jan 7.

Results Reference

background

PubMed Identifier

32653445

Citation

Bilgen F, Chen P, Poggi A, Wells J, Trumble E, Helmke S, Teruya S, Catalan T, Rosenblum HR, Cornellier ML, Karmally W, Maurer MS, Hummel SL. Insufficient Calorie Intake Worsens Post-Discharge Quality of Life and Increases Readmission Burden in Heart Failure. JACC Heart Fail. 2020 Sep;8(9):756-764. doi: 10.1016/j.jchf.2020.04.004. Epub 2020 Jul 8.

Results Reference

derived

PubMed Identifier

30354562

Citation

Hummel SL, Karmally W, Gillespie BW, Helmke S, Teruya S, Wells J, Trumble E, Jimenez O, Marolt C, Wessler JD, Cornellier ML, Maurer MS. Home-Delivered Meals Postdischarge From Heart Failure Hospitalization. Circ Heart Fail. 2018 Aug;11(8):e004886. doi: 10.1161/CIRCHEARTFAILURE.117.004886.

Results Reference

derived

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Geriatric Out of Hospital Randomized Meal Trial in Heart Failure

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