DASH Diet for Heart Failure

(DASH-HF Trial)

Not currently recruiting at 1 trial location

Overseen By Francene Steinberg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Low BMI, Cardiac cachexia, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the DASH diet can help people manage heart failure more effectively. Rich in fruits, vegetables, and low-fat dairy, the DASH diet aims to improve heart health. Participants will receive guidance on adopting this diet to determine if it improves their heart condition over six months. Individuals diagnosed with heart failure and on a stable medication plan for at least 30 days might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance heart health management for many.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires that your heart failure treatment is stable for at least 30 days before joining.

What prior data suggests that the DASH diet is safe for heart failure management?

Research has shown that the DASH diet is generally safe for most people. It can help lower cholesterol, unhealthy fats, and blood pressure, making it a popular choice for managing high blood pressure, also known as hypertension.

Following the DASH diet over a long period has been linked to a lower risk of heart failure. In previous studies, people who followed the DASH diet experienced fewer heart problems over time. Importantly, very few negative side effects have been reported with this diet. However, limited long-term safety data prevents experts from making final conclusions.

Overall, the DASH diet is easy to follow and is considered a healthy eating plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for heart failure, which often include medications like ACE inhibitors, beta-blockers, and diuretics, the DASH diet focuses on nutritional and lifestyle changes to manage the condition. The DASH diet is unique because it emphasizes whole foods rich in nutrients that support heart health, such as fruits, vegetables, and low-fat dairy, while reducing sodium and unhealthy fats. Researchers are excited about this approach because it offers a non-pharmaceutical option that may improve heart failure outcomes by promoting overall cardiovascular health and potentially reducing the need for medication. Additionally, this dietary approach empowers patients with practical tools to make lasting lifestyle changes that could enhance their quality of life.

What evidence suggests that the DASH diet might be an effective treatment for heart failure?

Research has shown that the DASH diet effectively manages heart failure by helping to lower blood pressure, potentially preventing the condition. Within 12 weeks, the diet has reduced certain heart-related indicators, such as cardiac troponin I and hs-CRP. These changes suggest that the DASH diet can enhance heart health and reduce the risk of heart failure. Although few side effects have been reported, more information on long-term safety is needed. Overall, the DASH diet has demonstrated promising results in managing heart health. Participants in this trial will receive nutrition education and medical nutrition therapy counseling focused on implementing and adhering to the DASH diet for heart failure management. ^{3 5 6 7 8}

Who Is on the Research Team?

Francene Steinberg, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for heart failure patients who have been on a stable, optimized medical regimen for at least 30 days. It's not suitable for individuals with a BMI under 18.5, those experiencing severe weight loss due to illness (cardiac cachexia), end-stage kidney disease or dialysis, ongoing inflammation, uncontrolled heart rhythm problems or ischemia, or those who've had a heart transplant or have an implanted heart pump.

Inclusion Criteria

I have been diagnosed with heart failure.

My current treatment for my condition has been stable for at least 30 days.

Exclusion Criteria

You have had a heart transplant or have a device to help your heart pump.

Your body mass index (BMI) is below 18.5.

I have irregular heartbeats or heart issues not managed by medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutrition education and medical nutrition therapy counseling focusing on DASH diet implementation and adherence for heart failure management

6 months

4 visits (in-person) at 1, 2, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of dietary intake, blood pressure, and heart failure symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DASH diet

Trial Overview

The study is examining the effectiveness of the DASH diet—a dietary approach to stop hypertension—in managing outpatient heart failure. Researchers will use behavioral assessments and clinical tests to measure how well this diet works in improving patient health.

How Is the Trial Designed?

Group I: Dietary Intervention Arm Experimental Treatment 1 Intervention

Subjects will receive the active intervention of nutrition education and medical nutrition therapy counseling for dietary and behavioral lifestyle changes. The focus will be on DASH diet implementation and adherence for management of heart failure. The subjects will have 4 study visits with a Registered Dietitian over 6 months (visits at 1, 2, 3, and 6 months). Outcome measures will be assessed at baseline, 3 and 6 months.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

American College of Cardiology

Collaborator

Trials

18

Recruited

312,000+

Published Research Related to This Trial

The OmniHeart study is a randomized crossover trial involving 160 adults with prehypertension or Stage 1 hypertension, designed to compare the effects of a carbohydrate-rich diet with diets high in protein or unsaturated fat on blood pressure and cholesterol levels.

The study aims to provide insights into how different macronutrient compositions can influence cardiovascular risk factors, potentially guiding dietary recommendations for better heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). Carey, VJ., Bishop, L., Charleston, J., et al.[2017]

Adherence to the DASH diet is linked to a lower risk of developing heart failure (HF) in a diverse population of adults aged 45 and older, with significant reductions in risk observed in those under 75 years old.

The study analyzed data from the REGARDS cohort, finding that individuals in higher DASH diet score quartiles had a reduced hazard ratio for incident HF, indicating that a healthier diet may help prevent heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) Diet Pattern and Incident Heart Failure. Goyal, P., Balkan, L., Ringel, JB., et al.[2023]

In a study of 36,019 women aged 48 to 83, those who closely followed the DASH diet had a 37% lower rate of heart failure (HF) over 7 years compared to those who did not, even after adjusting for various health and lifestyle factors.

The results suggest that adherence to the DASH diet is linked to a significant reduction in the risk of heart failure, indicating its potential as a preventive dietary approach for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consistency with the DASH diet and incidence of heart failure. Levitan, EB., Wolk, A., Mittleman, MA.[2021]

Heart failure (HF) patients often face complex challenges due to deranged physiology and malnutrition, making effective nutritional strategies crucial for their care.

The DASH (Dietary Approaches to Stop Hypertension) diet may be particularly beneficial for HF patients, as it aligns with the need for a dietary program that supports both nutritional needs and HF management goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. Rifai, L., Silver, MA.[2019]

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10551663/

DASH Diet: A Review of Its Scientifically Proven Hypertension ...

The DASH diet has exhibited notable efficacy in addressing an array of conditions such as heart failure, lipid homeostasis, dyslipidemia, and uric acid ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.122.026684

Effects of the Dietary Approaches to Stop Hypertension ...

In comparison with a typical American diet, the DASH diet reduced high‐sensitivity cardiac troponin I and hs‐CRP progressively over 12 weeks.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6527445/

Dietary Approaches to Stop Hypertension Diet Concordance ...

This study supports the hypothesis that DASH is beneficial in heart failure prevention within the individuals aged less than 75 years subgroup.

4.

academic.oup.com

academic.oup.com/eurjpc/article/29/7/1114/6496949

DASH diet is associated with a lower risk of heart failure

Trials demonstrate that following the DASH diet lowers blood pressure, which may prevent the development of heart failure (HF). We investigated ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40326569/

Dietary Approaches to Stop Hypertension (DASH) for the ...

Although the DASH diet has minimal reported adverse effects, the absence of long-term safety data prevents definitive conclusions on its use in ...

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ncbi.nlm.nih.gov

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DASH Diet To Stop Hypertension - StatPearls - NCBI Bookshelf

The diet has been tested in several clinical trials and has been shown to lower cholesterol, saturated fats, and blood pressure.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8396128/

The Dietary Approaches to Stop Hypertension (DASH) Diet ...

Compared to the lowest quartile, individuals in the 2nd-4th DASH diet score quartiles had lower risk for incident HF after adjustment for sociodemographic and ...

8.

mayoclinic.org

mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/dash-diet/art-20048456

DASH diet: Healthy eating to lower your blood pressure

The DASH diet is a healthy-eating plan designed to help prevent or treat high blood pressure, also called hypertension.