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Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF)

University of Georgia (UGA) logo

University of Georgia (UGA)

Status

Not yet enrolling

Conditions

Heart Failure

Treatments

Other: Dietary Approaches to Stop Hypertension Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06296862
STUDY00005563

Details and patient eligibility

About

The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use.

Enrollment

38 estimated patients

Sex

All

Ages

65 to 110 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 65+ years of age
  • Heart failure diagnosis and symptoms, as outlined by the 2021 European Society of Cardiology diagnostic guidelines
  • Residence within 50 miles of Emory University
  • Have undergone hemodynamic monitoring device implantation (CardioMEMS, Abbott)
  • Have received optimized HF therapy for 3+ months post CardioMEMS implantation

Exclusion criteria

  • Heart failure-related hospitalization or heart failure medication changes within 1 month
  • Renal disease stages IV-V
  • Expected survival < 12 months
  • Dementia or Alzheimer's disease
  • Limited English literacy and communication skills

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

38 participants in 2 patient groups

Dietary Approaches to Stop Hypertension Diet
Experimental group
Treatment:
Other: Dietary Approaches to Stop Hypertension Diet
Usual Diet
No Intervention group

Trial contacts and locations

1

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Central trial contact

Elisabeth LP Sattler, PhD, RPh

Data sourced from clinicaltrials.gov

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