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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).

ABSTRACT: Heart failure (HF) is a major public health problem affecting predominantly older adults. Nonadherence to diet remains a significant contributor to acute decompensated HF (ADHF). The sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines. We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and improve health-related quality of life (QOL) in older adults after hospitalization for ADHF.This is a 3-center, randomized, single-blind, controlled trial of 12-week duration designed to determine the safety and efficacy of home-delivered DASH/SRD-compliant meals in older adults after discharge from ADHF hospitalization. Sixty-six subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (<50% vs ?50%). Study subjects will receive either preprepared, home-delivered DASH/SRD-compliant meals or usual dietary advice for 4weeks after hospital discharge. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until study completion. The primary efficacy end point is the change in the Kansas City Cardiomyopathy Questionnaire summary scores for health-related QOL from study enrollment to 4weeks postdischarge. Safety evaluation will focus on hypotension, renal insufficiency, and hyperkalemia. Exploratory end points include echocardiography, noninvasive vascular testing, markers of oxidative stress, and salt taste sensitivity.This randomized controlled trial will test the efficacy, feasibility, and safety of 4weeks of DASH/SRD after ADHF hospitalization. By testing a novel dietary intervention supported by multiple levels of evidence including preliminary data in outpatients with stable HF, we will address a critical evidence gap in the care of older patients with ADHF. If effective and safe, this intervention could be scaled to assess effects on readmission and healthcare costs in older adults after ADHF.

SUBMITTER: Wessler JD

PROVIDER: S-EPMC4596079 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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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).

Wessler Jeffrey D JD Maurer Mathew S MS Hummel Scott L SL

American heart journal 20150107 3

<h4>Background</h4>Heart failure (HF) is a major public health problem affecting predominantly older adults. Nonadherence to diet remains a significant contributor to acute decompensated HF (ADHF). The sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines. We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and ...[more]

PMID: 25728723

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Project description:AimsHeart failure (HF) readmission commonly arises owing to insufficient patient knowledge and failure of recognition of the early stages of recurrent fluid congestion. In previous work, we developed a score to predict short-term hospital readmission and showed that higher-risk patients benefit most from a disease management programme (DMP) that included enhancing knowledge and education by a nurse. We aim to evaluate the effectiveness of a novel, nurse-led HF DMP in selected patients at high risk of short-term hospital readmission, using ultrasound-guided diuretic management and artificial intelligence to enhance HF knowledge in an outpatient setting.Methods and resultsRisk-HF is a prospective multisite randomized controlled trial that will allocate 404 patients hospitalized with acute decompensated HF, and ≥33% risk of readmission and/or death at 30 days, into risk-guided nurse intervention (DMP-Plus group) compared with usual care. Intervention elements include (i) fluid management with a handheld ultrasound (HHU) device at point of care; (ii) post-discharge follow-up; (iii) optimal programmed drug titration; (iv) better transition of care; (v) intensive self-care education via an avatar-based 'digital health coach'; and (vi) exercise guidance through the digital coach. Usual care involves standard post-discharge hospital care. The primary outcome is reduced death and/or hospital readmissions at 30 days post-discharge, and secondary outcomes include quality of life, fluid management efficacy, and feasibility and patient engagement. Assuming that our intervention will reduce readmissions and/or deaths by 50%, with a 1:1 ratio of intervention vs. usual care, we plan to randomize 404 patients to show a difference at a statistical power of 80%, using a two-sided alpha of 0.05. We anticipate this recruitment will be achieved by screening 2020 hospitalized HF patients for eligibility. An 8 week pilot programme of our digital health coach in 21 HF patients, age > 75 years, showed overall improvements in quality of life (13 of 21), self-care (12 of 21), and HF knowledge (13 of 21). A pilot of the use of HHU by nurses showed that it was feasible and accurate.ConclusionsThe Risk-HF trial will evaluate the effectiveness of a risk-guided intervention to improve HF outcomes and will evaluate the efficacy of trained HF nurses delivering a fluid management protocol that is guided by lung ultrasound with an HHU at point of care.

Project description:BackgroundDisease management programmes (DMPs) have been shown to reduce hospital readmissions and mortality in adults with heart failure (HF), but their effectiveness in elderly patients or in those with major comorbidity is unknown. The Multicenter Randomised Trial of a Heart Failure Management Programme among Geriatric Patients (HF-Geriatrics) assesses the effectiveness of a DMP in elderly patients with HF and major comorbidity.Methods/designClinical trial in 700 patients aged ≥ 75 years admitted with a primary diagnosis of HF in the acute care unit of eight geriatric services in Spain. Each patient should meet at least one of the following comorbidty criteria: Charlson index ≥ 3, dependence in ≥ 2 activities of daily living, treatment with ≥ 5 drugs, active treatment for ≥ 3 diseases, recent emergency hospitalization, severe visual or hearing loss, cognitive impairment, Parkinson's disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), anaemia, or constitutional syndrome. Half of the patients will be randomly assigned to a 1-year DMP led by a case manager and the other half to usual care. The DMP consists of an educational programme for patients and caregivers on the management of HF, COPD (knowledge of the disease, smoking cessation, immunizations, use of inhaled medication, recognition of exacerbations), diabetes (knowledge of the disease, symptoms of hyperglycaemia and hypoglycaemia, self-adjustment of insulin, foot care) and depression (knowledge of the disease, diagnosis and treatment). It also includes close monitoring of the symptoms of decompensation and optimisation of treatment compliance. The main outcome variables are quality of life, hospital readmissions, and overall mortality during a 12-month follow-up.DiscussionThe physiological changes, lower life expectancy, comorbidity and low health literacy associated with aging may influence the effectiveness of DMPs in HF. The HF-Geriatrics study will provide direct evidence on the effect of a DMP in elderly patients with HF and high comorbidty, and will reduce the need to extrapolate the results of clinical trials in adults to elderly patients.Trial registration(ClinicalTrials.gov number, NCT01076465).

Dataset Information

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).

Publications

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).

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