What side effects are associated with this type of intervention?

Common treatments for heart failure that involve nutritional support or dietary guidance include low-sodium diets, fluid restriction, and supplementation with specific nutrients such as potassium, magnesium, and vitamins. Known side effects of these treatments can include electrolyte imbalances (e.g., hyperkalemia or hypokalemia), dehydration, and potential interactions with medications. Additionally, patients may experience gastrointestinal issues such as nausea or constipation when adjusting to new dietary regimens. It is important for patients to work closely with their healthcare providers to monitor and manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for heart failure, primarily focusing on medications such as ACE inhibitors, beta-blockers, diuretics, and more recently, angiotensin receptor-neprilysin inhibitors (ARNIs). While these pharmacological treatments are well-established, the role of nutritional support in heart failure management is gaining attention. Nutritional interventions, such as providing additional nutrients or dietary guidance, aim to improve patient outcomes by addressing malnutrition and cachexia, which are common in heart failure patients. Although specific FDA approvals for nutritional support in heart failure are limited, ongoing clinical trials, like the GOURMET-VA study, are investigating the efficacy and safety of such interventions.

What other types of research exist?

Promising novel alternatives to nutritional support for heart failure patients include: 1) SGLT2 inhibitors, which have shown significant benefits in reducing heart failure hospitalizations and cardiovascular mortality. 2) Cardiac contractility modulation (CCM) devices, which improve heart muscle function and quality of life. 3) Gene therapy targeting specific genetic mutations associated with heart failure. 4) Advanced remote monitoring technologies for early detection and management of heart failure exacerbations. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Behavioural Intervention

Nutritional Support for Heart Failure (GOURMET-VA Trial)

Q: What is the mechanism of action of this treatment?

Nutritional support in Heart Failure (HF) patients aims to address malnutrition, improve energy levels, and enhance overall health, leading to better clinical outcomes. By ensuring adequate intake of essential nutrients, these interventions help maintain muscle mass, reduce inflammation, and improve cardiac function. This is crucial for HF patients who often suffer from cachexia and muscle wasting, conditions that can worsen symptoms and reduce quality of life.

N/A

Waitlist Available

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized (24 hours) with new HF or worsening chronic HF

Aged 60 years

Must not have

On dialysis or estimated glomerular filtration rate <30 at randomization

Planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where Veteran does not have control over diet

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if extra help with nutrition, including more dietary education and counseling, can improve recovery for patients who have just left the hospital. The goal is to see if this added support is more effective than the usual care alone.

Who is the study for?

This trial is for Veterans aged 60+ who've been hospitalized with new or worsening heart failure, can eat and drink normally, and are enrolled in a VHA facility. It's not for those with severe dietary restrictions, kidney issues requiring dialysis, extreme obesity, cognitive impairments, or any conditions that limit their ability to control their diet or participate fully.

What is being tested?

The GOURMET-VA study is testing if adding home-delivered meals and short-term dietary counseling to the usual care (which includes standardized education and one dietary session post-discharge) improves outcomes for older adults with heart failure compared to usual care alone.

What are the potential side effects?

Since this trial involves nutritional support rather than medication, side effects may be minimal but could include potential food-related reactions based on individual tolerances. The standard of care might have its own set of risks depending on each patient's condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized for at least 24 hours due to new or worsening heart failure.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis or my kidney function is very low.

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I will be in a place where I can't control my diet after leaving the hospital.

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I have had a heart transplant or am on the transplant list.

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My life expectancy is less than 12 months due to my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life

Secondary study objectives

DAOH at 6 months post-discharge

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Home-delivered meals and short-term dietary counselingExperimental Treatment1 Intervention

Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.

Group II: ControlActive Control1 Intervention

Study-defined standard of care

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nutritional support in Heart Failure (HF) patients aims to address malnutrition, improve energy levels, and enhance overall health, leading to better clinical outcomes. By ensuring adequate intake of essential nutrients, these interventions help maintain muscle mass, reduce inflammation, and improve cardiac function. This is crucial for HF patients who often suffer from cachexia and muscle wasting, conditions that can worsen symptoms and reduce quality of life.