NCT04113291

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 1, 2019

Last Update Submit

October 1, 2020

Conditions

Heart FailureHeart Failure With Preserved Ejection Fraction

Keywords

DASH DietLow socioeconomic statusHFPEF

Outcome Measures

Primary Outcomes (3)

  • Number of enrolled participants per week

    Up to week 12

  • Proportion of participants that adhere to the to intervention

    Up to week 12

  • Number participants that were retained in the trial

    Up to week 12

Secondary Outcomes (1)

  • Proportion of participants that adhere to the diet

    Up to week 12

Other Outcomes (34)

  • Weight

    Baseline

  • Weight

    After intervention, Week 12

  • Waist circumference

    Baseline

  • +31 more other outcomes

Study Arms (2)

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.

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.

Other: Usual diet

Interventions

DASH DietOTHER

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.

Also known as: Dietary Approaches to Stop Hypertension
DASH diet group
Usual dietOTHER

12 weeks usual diet \<2300 mg Na/day

Attention Control Group

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will have an education level of less than college as a surrogate marker of LSES.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Claudia Campos, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 2, 2019

Study Start

December 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

October 5, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)