Trial Summary
What is the purpose of this trial?This study is trying to find out how best to improve common measures of health and survival in those diagnosed with heart failure with preserved ejection fraction (HFpEF) through the implementation of 4 weeks of an exercise training program consisting of high intensity interval training, dietary approaches to stop hypertension (DASH diet), or a combination of the two. Currently there are not established guidelines that have been shown to improve clinical end points in those with this HFpEF.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, medication non-compliance is listed as an exclusion criterion, so it's important to follow your prescribed medication regimen.
Is the DASH Diet and High-Intensity Exercise a promising treatment for heart failure?Yes, the DASH Diet and High-Intensity Exercise are promising for heart failure. The DASH Diet helps lower blood pressure and reduce heart disease risk, while high-intensity exercise can improve heart health. Together, they may help manage heart failure effectively.46789
What safety data exists for the high fiber diet and high-intensity exercise treatment for heart failure?The DASH diet, which is part of the treatment, is known to effectively reduce blood pressure and improve cardiovascular risk factors. It is generally considered safe, but adherence is crucial for maximizing benefits. The safety of high-intensity exercise, such as HIIT, is not directly addressed in the provided research, but it is typically safe for most individuals when properly supervised and tailored to the participant's fitness level.12459
What data supports the idea that High Fiber Diet + High-Intensity Exercise for Heart Failure is an effective treatment?The available research shows that the DASH diet, which is part of the High Fiber Diet + High-Intensity Exercise treatment, is effective in lowering blood pressure and reducing cardiovascular risk factors. This suggests it could be beneficial for heart failure as well. However, the studies specifically on heart failure have shown mixed results, indicating that while the diet may help prevent heart failure, its effectiveness as a treatment is not fully clear. Compared to other treatments, the DASH diet is recognized for its ability to lower blood pressure, which is a key factor in managing heart health.23589
Eligibility Criteria
This trial is for people over 40 with heart failure where the heart pumps normally (HFpEF) and mild to moderate symptoms. They must be cleared by a doctor for exercise and the DASH diet, fully vaccinated against COVID-19, and not have had recent severe heart issues or conditions that prevent them from exercising or following the diet.Inclusion Criteria
I have moderate to severe heart symptoms.
I am 40 years old or older.
I am fully vaccinated against COVID-19.
I have been diagnosed with a type of heart failure where the heart muscle pumps normally.
Exclusion Criteria
I have heart failure that is not well-managed.
I have had a recent blood clot in my lung.
My high blood pressure is not under control.
I have severe symptoms from a narrowed heart valve.
I have been diagnosed with acute myocarditis.
I have unstable chest pain.
I have severe heart symptoms that limit my daily activities.
Treatment Details
The study tests if high-intensity interval exercise, a healthy eating plan called the DASH diet, or both combined can improve health in those with HFpEF. Participants will follow their assigned programs for four weeks to see which method works best.
3Treatment groups
Experimental Treatment
Group I: High Intensity Interval ExerciseExperimental Treatment1 Intervention
Enrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks.
Group II: Exercise + DASH DietExperimental Treatment1 Intervention
Enrolled subjects will undergo both the exercise training visits and be provided with the DASH diet.
Group III: Dietary Approaches to Stop Hypertension (DASH) DietExperimental Treatment1 Intervention
Enrolled patients will have all of their food prepared for them by a registered dietician for the duration of the study period. The diet will consist of a high fiber content DASH diet.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Virginia University HospitalCharlottesville, VA
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Who is running the clinical trial?
University of VirginiaLead Sponsor
Grain Foods FoundationCollaborator
References
Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). [2017]The DASH (Dietary Approaches to Stop Hypertension) diet is a carbohydrate-rich, reduced-fat diet that lowers blood pressure (BP) and LDL-cholesterol. Whether partial replacement of some carbohydrate (C) with either protein (P) or unsaturated fat (U) can further improve these and other cardiovascular (CVD) risk factors is unknown.
Deteriorating dietary habits among adults with hypertension: DASH dietary accordance, NHANES 1988-1994 and 1999-2004. [2016]Although the DASH (Dietary Approaches to Stop Hypertension trial) diet is among the therapeutic lifestyle changes recommended for individuals with hypertension (HTN), accordance with the DASH diet is not known.
Association between a DASH-like diet and mortality in adults with hypertension: findings from a population-based follow-up study. [2023]Although the Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP) in hypertensive adults, its effect on mortality is unclear.
Consistency with the DASH diet and incidence of heart failure. [2021]The Dietary Approaches to Stop Hypertension (DASH) diet effectively reduces blood pressure. In observational studies, the association between diets consistent with DASH and risk of coronary heart disease and stroke has been examined with varying results. We hypothesized that diets consistent with the DASH diet would be associated with a lower incidence of heart failure (HF).
Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023]The Dietary Approaches to Stop Hypertension (DASH) diet has been recognized as effective to lower blood pressure in feeding trials, but compliance with the diet must be persistent to maximize health benefits in clinical practice. This paper reports a systematic review of the latest evidence on the method to assess DASH compliance and the corresponding patients' compliance in interventional settings.
Mediterranean and Dietary Approaches to Stop Hypertension dietary patterns and risk of sudden cardiac death in postmenopausal women. [2023]The Mediterranean and Dietary Approaches to Stop Hypertension (DASH) diets are characterized by higher intake of fruit, vegetables, whole grains, and unsaturated fatty acids. All of these foods and nutrients may affect cholesterol, inflammation, the development of atherosclerosis, and, therefore, risk of cardiac death.
A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. [2019]Despite tremendous focus, effort, drug and device development and resources dedicated to the care of patients at risk for and with heart failure (HF), the epidemic continues. The HF patient presents with a widely deranged physiology and typically at the same time is malnourished adding to the disease complexity and therapeutic challenges. Most nutritional approaches for patients with HF focus on dietary restrictions (of salt and water) and lack uniformity or clarity or focus on meeting nutritional needs, barriers and deficits of the patient with HF. Finally, it seems reasonable to anticipate that any dietary program recommendation should contribute in a positive way toward HF management goals and at its foundation positively contribute to the deranged physiology. In many ways the "Dietary Approaches to Stop Hypertension" (DASH) dietary program fulfills these needs and early evidence supports the notion that the DASH diet may be optimal for patients with HF. This brief review examines some of this evidence and provides recommendations for the HF community.
The Dietary Approaches to Stop Hypertension (DASH) Diet Pattern and Incident Heart Failure. [2023]The Dietary Approaches to Stop Hypertension (DASH) diet pattern has shown some promise for preventing heart failure (HF), but studies have been conflicting.
The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]The dietary approaches to stop hypertension (DASH) encourages high fruit, vegetable, and lean protein consumption and low salt, red meat, and fat intake to prevent or treat hypertension. However, besides hypertension, adherence to this diet has been shown to decrease other cardiovascular risk factors.