Heart FailureDASH-HFNCT05117086
DASH Diet in Heart Failure Outpatients
A study testing DASH diet in people with Heart Failure, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- DASH diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Failure diagnosis
- Guideline directed medical therapy optimization on stable regimen at least 30 days
Who cannot join
- BMI < 18/5 kg/m squared
- cardiac cachexia
- end-stage renal disease or dialysis
- acute inflammatory condition
- uncontrolled arrhythmias or ischemia
- status post heart transplant or implanted left ventricular assist device
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Health Center - Cardiology Department
Sacramento, California, 95817
About this study
Official title: DASH Diet in Heart Failure Pilot Study - Integration and Effectiveness of Medical Nutrition Therapy Counseling on DASH Diet in the Management of Heart Failure Patients in an Academic Outpatient Cardiology Clinic
The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches.
Read the detailed description
The overall objective of this pilot study is to refine the classification of the effectiveness of the DASH diet for outpatient HF management using behavioral, clinical, and laboratory correlative science approaches. The investigators will integrate the use and evaluation of DASH diet nutrition education in a clinical population using a pragmatic study approach. The investigators will assess dietary behavior change. The investigators will assess the medical effectiveness of the DASH diet to improve patient symptomology and clinical biomarkers. Exploratory investigations will involve metabolomics analyses of plasma samples for biomarker discovery of clinical phenotypes in HF patients, to characterize metabolic profiles related to dietary exposure.
- Conditions
- Heart Failure
- Being tested
- DASH diet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietBehavioural
Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention Arm | Experimental | 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. Receives: Behavioral: DASH diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intake
Dietary intake assessed by nutrient analysis of food records
Measured: Dietary intake at baseline
Dietary intake
Dietary intake assessed by nutrient analysis of food records
Measured: Dietary intake at 3 months
Dietary intake
Dietary intake assessed by nutrient analysis of food records
Measured: Dietary intake at 6 months
Diet score
Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.
Measured: Dietary intake at baseline
Diet score
Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.
Measured: Dietary intake at 3 months
Diet score
Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.
Measured: Dietary intake at 6 months
Blood Pressure
Blood Pressure assessed with systolic and diastolic pressure
Measured: Systolic and diastolic Blood Pressure at baseline
Blood Pressure
Blood Pressure assessed with systolic and diastolic pressure
Measured: Systolic and diastolic Blood Pressure at 3 months
Blood Pressure
Blood Pressure assessed with systolic and diastolic pressure
Measured: Systolic and diastolic Blood Pressure at 6 months
Secondary outcomes (9)
Heart Failure clinical marker
proBNP will be assessed as a marker of severity of heart failure
Measured: proBNP at baseline
Heart Failure clinical marker
proBNP will be assessed as a marker of severity of heart failure
Measured: proBNP at 3 months
Heart Failure clinical marker
proBNP will be assessed as a marker of severity of heart failure
Measured: proBNP at 6 months
Patient report of HF symptoms
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Measured: KCCQ at baseline
Patient report of HF symptoms
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Measured: KCCQ at 3 months
Patient report of HF symptoms
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
Measured: KCCQ at 6 months
Patient report of eating habit self efficacy
Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.
Measured: Eating Habits at Baseline
Patient report of eating habit self efficacy
Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.
Measured: Eating Habits at 3 months
Patient report of eating habit self efficacy
Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.
Measured: Eating Habits at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pragmatic trial with pre- and post- assessments
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Cardiology
- Responsible party
- Sponsor
- Investigators
- Francene Steinberg, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117086
- Sponsor's protocol ID
- 1770356
- Acronym
- DASH-HF
- Status last verified
- Jun 2026
- First submitted
- 1 Nov 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DASH Diet in Heart Failure Pilot Study - Integration and Effectiveness of Medical Nutrition Therapy Counseling on DASH Diet in the Management of Heart Failure Patients in an Academic Outpatient Cardiology Clinic
- ClinicalTrials.gov ID
- NCT05117086
- Acronym / sponsor ID
- DASH-HF / 1770356
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- American College of Cardiology
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches.
Detailed description
The overall objective of this pilot study is to refine the classification of the effectiveness of the DASH diet for outpatient HF management using behavioral, clinical, and laboratory correlative science approaches. The investigators will integrate the use and evaluation of DASH diet nutrition education in a clinical population using a pragmatic study approach. The investigators will assess dietary behavior change. The investigators will assess the medical effectiveness of the DASH diet to improve patient symptomology and clinical biomarkers. Exploratory investigations will involve metabolomics analyses of plasma samples for biomarker discovery of clinical phenotypes in HF patients, to characterize metabolic profiles related to dietary exposure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pragmatic trial with pre- and post- assessments
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention Arm | Experimental | Behavioral: DASH dietSubjects 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 may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart Failure diagnosis
- Guideline directed medical therapy optimization on stable regimen at least 30 days
Key exclusion criteria (6 listed)
- BMI < 18/5 kg/m squared
- cardiac cachexia
- end-stage renal disease or dialysis
- acute inflammatory condition
- uncontrolled arrhythmias or ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH dietNutrition education and counseling on DASH diet, behavioral and lifestyle modifications | Behavioural | Dietary Intervention Arm |
Primary outcome
Dietary intake
Time frame: Dietary intake at baseline
Dietary intake assessed by nutrient analysis of food records
Dietary intake
Time frame: Dietary intake at 3 months
Dietary intake assessed by nutrient analysis of food records
Dietary intake
Time frame: Dietary intake at 6 months
Dietary intake assessed by nutrient analysis of food records
Diet score
Time frame: Dietary intake at baseline
Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.
Diet score
Time frame: Dietary intake at 3 months
Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.
Diet score
Time frame: Dietary intake at 6 months
Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.
Blood Pressure
Time frame: Systolic and diastolic Blood Pressure at baseline
Blood Pressure assessed with systolic and diastolic pressure
Blood Pressure
Time frame: Systolic and diastolic Blood Pressure at 3 months
Blood Pressure assessed with systolic and diastolic pressure
Blood Pressure
Time frame: Systolic and diastolic Blood Pressure at 6 months
Blood Pressure assessed with systolic and diastolic pressure
9 secondary outcomes
Heart Failure clinical marker
Time frame: proBNP at baseline
Heart Failure clinical marker
Time frame: proBNP at 3 months
Heart Failure clinical marker
Time frame: proBNP at 6 months
Patient report of HF symptoms
Time frame: KCCQ at baseline
Patient report of HF symptoms
Time frame: KCCQ at 3 months
Patient report of HF symptoms
Time frame: KCCQ at 6 months
Patient report of eating habit self efficacy
Time frame: Eating Habits at Baseline
Patient report of eating habit self efficacy
Time frame: Eating Habits at 3 months
Patient report of eating habit self efficacy
Time frame: Eating Habits at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francene Steinberg, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH diet in people with Heart Failure, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary intake (time frame: Dietary intake at baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.