Geriatric Out of Hospital Randomized Meal Trial in Heart Failure

NCT02148679 | Completed

• 2 other identifiers: HUM00083272R21AG047939
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 3

Brief Summary

Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge.

Conditions

Heart Failure

Keywords

Heart Failure; Diet

Outcome Measures

Primary Outcomes (1)

• 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.

  from study enrollment to 4 weeks post-discharge

Secondary Outcomes (3)

• Safety Monitoring

  Baseline and 1 week post discharge

• Dietary Endpoints

  baseline, 4 weeks

• Mechanism-related endpoints

  Baseline to 4 weeks

Study Arms (2)

DASH/SRD

EXPERIMENTAL

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

Other: DASH/SRD

Attention Control

PLACEBO COMPARATOR

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

Other: DASH/SRD; Other: Usual care

Interventions

DASH/SRD OTHER

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.

Also known as: Mom's Meals

Attention Control; DASH/SRD

Usual care OTHER

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

Attention Control

Eligibility Criteria

• Age: 55 Years+
• Gender Eligibility Details: eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• PurFoods, LLC: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Ann Arbor Veterans Affairs Health System

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Related Publications (9)

• 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.

  PMID: 19854331 BACKGROUND

• 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.

  PMID: 23033371 BACKGROUND

• 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.

  PMID: 23985432 BACKGROUND

• 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.

  PMID: 15246908 BACKGROUND

• 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.

  PMID: 20200258 BACKGROUND

• 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.

  PMID: 23102175 BACKGROUND

• 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.

  PMID: 25728723 BACKGROUND

• 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.

  PMID: 32653445 DERIVED

• 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.

  PMID: 30354562 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Scott L Hummel, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: May 21, 2017
• Study Completion: July 1, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

US (3)