Heart FailureDASHFNCT04113291
Randomized Controlled Pilot Trial of DASH Feeding in Older Low Socioeconomic Adults Without Heart Failure
A study testing DASH Diet and Usual diet in people with Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- DASH Diet and Usual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will have an education level of less than college as a surrogate marker of LSES.
Who cannot join
- Participants should not have a diagnosis of heart failure or loop diuretics on their medication list in the EHR or symptoms of dyspnea, edema (assessed via questionnaire)
- poorly controlled diabetes mellitus ( HBA 1c >9%)
- or uncontrolled hypertension ( SBP>180, DBP>110)
- cardiovascular event (MI, stroke, HF, angina, atrial fibrillation) within the previous six months
- chronic diseases that might interfere with participation (dementia, schizophrenia, dialysis or transplant recipient patients)
- body-mass index (the weight in kilograms divided by the square of the height in meters) of more than 35
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure
This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.
Read the detailed description
This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).
- Being tested
- DASH Diet, Usual diet
- Keywords
- DASH Diet, Low socioeconomic status, HFPEF
- 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 DietOther
Also called Dietary Approaches to Stop Hypertension
12 Weeks of isocaloric DASH diet <2300 mg Na/day using meals (lunch, dinner, snacks) prepared by the Wake Forest Clinical Research Metabolic Kitchen under the direction of a registered dietician (RD). Participants will prepare their own breakfast from a menu.The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day.
Usual dietOther
12 weeks usual diet <2300 mg Na/day
| Study group | Role | What they receive |
|---|---|---|
| DASH diet group | Experimental | Participants randomized to receive the DASH diet will be prescribed an isocaloric DASH diet using meals (lunch, dinner, snacks) prepared by a Clinical Research Metabolic Kitchen under the direction of a registered dietician. Participants will prepare their own breakfast from a menu. The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day. Receives: Other: DASH Diet |
| Attention Control Group | Active comparator | Participants randomized to attention control will continue their usual diet, but they will be instructed to limit their sodium intake to 2300 mg/day. They will be requested and voluntarily agree to not make additional diet or exercise changes during the 12-week study. Receives: Other: Usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enrolled participants per week
Measured: Up to week 12
Proportion of participants that adhere to the to intervention
Measured: Up to week 12
Number participants that were retained in the trial
Measured: Up to week 12
Secondary outcomes (1)
Proportion of participants that adhere to the diet
Measured: Up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study startDec 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: Insufficient funding
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 Wake Forest University Health SciencesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Campos, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113291
- Sponsor's protocol ID
- DASHF-PRE
- Acronym
- DASHF
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2019
- Last updated
- 5 Oct 2020
- 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 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure
- ClinicalTrials.gov ID
- NCT04113291
- Acronym / sponsor ID
- DASHF / DASHF-PRE
- Keywords
- DASH Diet, Low socioeconomic status, HFPEF
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 2 Oct 2019 (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.
This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.
Detailed description
This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH diet group | Experimental | Other: DASH DietParticipants randomized to receive the DASH diet will be prescribed an isocaloric DASH diet using meals (lunch, dinner, snacks) prepared by a Clinical Research Metabolic Kitchen under the direction of a registered dietician. Participants will prepare their own breakfast from a menu. The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day. |
| Attention Control Group | Active comparator | Other: Usual dietParticipants randomized to attention control will continue their usual diet, but they will be instructed to limit their sodium intake to 2300 mg/day. They will be requested and voluntarily agree to not make additional diet or exercise changes during the 12-week study. |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will have an education level of less than college as a surrogate marker of LSES.
Key exclusion criteria (6 listed)
- Participants should not have a diagnosis of heart failure or loop diuretics on their medication list in the EHR or symptoms of dyspnea, edema (assessed via questionnaire)
- poorly controlled diabetes mellitus ( HBA 1c >9%)
- or uncontrolled hypertension ( SBP>180, DBP>110)
- cardiovascular event (MI, stroke, HF, angina, atrial fibrillation) within the previous six months
- chronic diseases that might interfere with participation (dementia, schizophrenia, dialysis or transplant recipient patients)
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 DietAlso: Dietary Approaches to Stop Hypertension12 Weeks of isocaloric DASH diet <2300 mg Na/day using meals (lunch, dinner, snacks) prepared by the Wake Forest Clinical Research Metabolic Kitchen under the direction of a registered dietician (RD). Participants will prepare their own breakfast from a menu.The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day. | Other | DASH diet group |
| Usual diet12 weeks usual diet <2300 mg Na/day | Other | Attention Control Group |
Primary outcome
Number of enrolled participants per week
Time frame: Up to week 12
Proportion of participants that adhere to the to intervention
Time frame: Up to week 12
Number participants that were retained in the trial
Time frame: Up to week 12
1 secondary outcome
Proportion of participants that adhere to the diet
Time frame: Up to week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- 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.
Claudia Campos, MD principal investigator
Wake Forest University Health Sciences
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 and Usual diet in people with Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Wake Forest University Health Sciences 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 1 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: withdrawn, as of the sponsor's last update on 5 Oct 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of enrolled participants per week (time frame: Up to week 12). The study lists 3 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 5 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.