Low-Sodium, High-Quality Diet for Heart Failure Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a low-sodium, high-quality diet can prevent heart failure in Veterans with preserved ejection fraction (HFpEF), a type of heart failure. Participants will follow a special diet called DASH/SRD to assess its impact on heart health. The study compares two groups: one will receive dietary counseling plus digital support (WHEELS-I), while the other will receive only counseling. Veterans with high blood pressure, obesity, and metabolic syndrome (issues with cholesterol and insulin) who are willing to use a smartphone app or email for support may be well-suited for this trial. As an unphased trial, this study provides Veterans the chance to contribute to significant research that could enhance heart health through dietary changes.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants can be on anti-hypertensive drugs, so you might be able to continue some medications. It's best to discuss this with the trial coordinators.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the sodium-restricted DASH (Dietary Approaches to Stop Hypertension) diet is safe for most people. Studies have found that this diet can improve heart health and lower blood pressure in individuals with heart issues. For instance, one study showed it reduced blood pressure and improved heart function. Another study noted that the DASH diet can make arteries less stiff and reduce oxidative stress, both linked to heart problems.
Evidence also supports that motivational interviewing, a method to encourage healthier habits, is safe. It helps people adhere to dietary changes without major side effects. The WHEELS-I program, which uses motivational interviewing, has not been known to cause harm because it promotes lifestyle changes through personalized messages.
In summary, the DASH diet and motivational interviewing with WHEELS-I are well-tolerated methods. They aim to improve heart health through diet and behavior changes, with no serious side effects reported in studies.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how a low-sodium diet can help prevent heart failure with preserved ejection fraction (HFpEF) by using a unique approach. The study focuses on the DASH/SRD diet, known for lowering blood pressure, combined with motivational interviewing, which helps participants adopt and stick to the diet. Additionally, the trial introduces WHEELS-I, an innovative, personalized digital messaging system designed to support lifestyle changes. This approach not only aims to improve heart health but also provides insights into how technology and personalized coaching can enhance diet adoption, potentially offering a more accessible and sustainable way to tackle heart disease compared to traditional methods.
What evidence suggests that this trial's dietary interventions could be effective for preventing heart failure with preserved ejection fraction?
Research has shown that following a low-sodium DASH (Dietary Approaches to Stop Hypertension) diet can improve heart health, particularly for those at risk of heart issues like heart failure with preserved ejection fraction (HFpEF). This diet is associated with better heart function and healthier blood vessels. Early findings suggest that reducing sodium intake can positively affect how the heart and arteries work together. In this trial, one group of participants will receive motivational interviewing-based counseling to encourage the adoption of the DASH/SRD eating plan. Another group will receive the same counseling along with the WHEELS-I program, an electronically-delivered tailored messaging intervention. This combination aims to help individuals adhere to this healthy eating plan, potentially preventing heart failure by enhancing overall heart health.14678
Who Is on the Research Team?
Scott L. Hummel, MD
Principal Investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
Are You a Good Fit for This Trial?
This trial is for Veterans aged 45+ with high blood pressure and metabolic syndrome, which includes obesity or a large waist size. They must be willing to use a smartphone app or email for the WHEELS-I program. It's not open to those with recent heart attacks, uncontrolled diabetes, severe heart conditions, very high blood pressure, certain past illnesses like HFpEF, or who are in other studies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Crossover-Randomized Diet Comparison
Participants undergo a crossover-randomized comparison of DASH/SRD vs. control diet for two weeks each to evaluate salt-sensitivity.
Phase 2: DASH/SRD Adherence Promotion
Participants engage in a 6-month extension to promote DASH/SRD adherence, including motivational interviewing and tailored messaging.
Follow-up
Participants are monitored for safety and effectiveness after the dietary intervention.
What Are the Treatments Tested in This Trial?
Interventions
- Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors
- Performance of WHEELS-I in promoting DASH/SRD adoption
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor