DASH Diet for Heart Failure

Overseen By Elisabeth LP Sattler, PhD, RPh

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Georgia

Disqualifiers: Renal disease, Dementia, Alzheimer's, others

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

Compensation: Varies

Number of Visits: 11

38 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your existing heart failure treatment, as the study focuses on diet.

What data supports the effectiveness of the DASH Diet treatment for heart failure?

The DASH Diet, known for lowering blood pressure, may help manage heart failure by improving heart health and quality of life, especially when combined with sodium restriction. However, more rigorous studies are needed to confirm its benefits specifically for heart failure patients. ^{1 2 3 4 5}

Is the DASH diet safe for people with heart failure?

The DASH diet is generally safe for most people and can be adopted alongside medication and other lifestyle changes. However, caution is advised for those with chronic kidney or liver disease, and modifications may be needed for people with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease. ^{1 3 6 7 8}

How is the DASH diet treatment different for heart failure?

The DASH diet is unique for heart failure because it focuses on a high intake of fruits, vegetables, and lean proteins while reducing salt, red meat, and fat, which can help lower blood pressure and improve heart health. Unlike medications, it is a dietary approach that may prevent heart failure by addressing multiple cardiovascular risk factors. ^{1 3 7 9 10}

Eligibility Criteria

This trial is for older adults aged 65 and over who have heart failure. They must be able to attend four study visits at Emory GCRC and discuss their diet six times during the 12-week study. The trial seeks a total of 38 participants from specific Emory healthcare locations.

Inclusion Criteria

Residence within 50 miles of Emory University

I've been on heart failure treatment for over 3 months after getting a CardioMEMS device.

I am 65 years old or older.

Exclusion Criteria

Expected survival < 12 months

Limited English literacy and communication skills

My kidney function is severely reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or phone)

Dietary Intervention

Participants are randomized to eat only the DASH diet provided to them for 4 weeks

4 weeks

4 visits (in-person)

Control Phase

Participants follow their usual diet for 4 weeks

4 weeks

Dietary consumption assessed 6 times

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietary Approaches to Stop Hypertension Diet

Trial Overview The DASH (Dietary Approaches to Stop Hypertension) diet's impact on heart failure in seniors is being tested. Participants will follow this special diet strictly for one period of four weeks, either at the start or end of the study, with their health changes monitored closely.

Participant Groups

Group I: Dietary Approaches to Stop Hypertension Diet Experimental Treatment 1 Intervention

Group II: Usual Diet Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Findings from Research

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]

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]

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]

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]

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]

The DASH diet, which emphasizes fruits, vegetables, nuts, and low-fat dairy while reducing saturated fats, led to an average reduction of 6 mmHg in systolic and 3 mmHg in diastolic blood pressure among patients, with even greater reductions in those with high blood pressure.

These significant blood pressure reductions were observed within just 2 weeks of starting the diet, indicating its potential effectiveness for managing hypertension in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. Kolasa, KM.[2020]

A study involving 329 participants showed that following the DASH diet for 8 weeks resulted in significant changes in serum concentrations of 44 metabolites compared to a control diet and a fruit and vegetables diet, indicating the diet's impact on metabolic health.

The research identified a specific panel of 10 metabolites that can effectively distinguish adherence to the DASH diet, suggesting potential for these metabolites to be used as biomarkers for dietary assessment in cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum untargeted metabolomic profile of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. Rebholz, CM., Lichtenstein, AH., Zheng, Z., et al.[2023]

A study of 2,831 adults in Iran found that adherence to the DASH diet is associated with lower levels of cardiovascular risk factors, including blood pressure, fasting blood sugar, triglycerides, and cholesterol.

Specifically, individuals in the highest quintile of DASH diet adherence had a 28% lower odds of hyperglycemia, suggesting that the DASH diet may be effective in reducing the risk of diabetes and other cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. Shoaibinobarian, N., Danehchin, L., Mozafarinia, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) Diet Pattern and Incident Heart Failure. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Consistency with the DASH diet and incidence of heart failure. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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). [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Management of Heart Failure: DASH Diet and Precision Nutrition Perspectives. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Serum untargeted metabolomic profile of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. [2023]

10. Iran pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]