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Effect of DASH Eating Pattern on Heart Failure Outcomes (DASH HF)

Primary Purpose

Heart Failure NYHA Class III

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH Eating Pattern
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure NYHA Class III focused on measuring Nutrition, Dietary Approaches to Stop Hypertension, Cardiometabolic Outcomes, Pulmonary Artery Pressure, CardioMEMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18+ years of age
  2. English language literacy
  3. Diagnosis of HF ≥ 3 months
  4. Diagnosis of NYHA Class III HF (historical assessment)
  5. Subjects must be stable on HF medication regimen for one month prior to study entry
  6. At least 1 HF hospitalization within 24 months of enrollment
  7. BNP >200 pg/ml

Exclusion Criteria:

  1. Subjects who have had an unplanned HF-related hospitalization within 2 months of enrollment
  2. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are nonresponsive to diuretic therapy or who are on chronic renal dialysis
  3. Subjects likely to undergo heart transplantation within 2 months of enrollment
  4. Subjects with severe conditions limiting 6-month survival
  5. Unavailability during scheduled data collection points
  6. Cognitive impairment

Sites / Locations

  • University of Georgia Clinical and Translational Research UnitRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DASH Eating Pattern

Arm Description

The DASH eating pattern meals prepared for study participants will strictly follow DASH meal planning guidelines published by National Heart, Lung, and Blood Institute of the National Institutes of Health. During the intervention phase of the study, all participants will exclusively consume prepared meals and provided beverages which will be delivered to participants' homes. Meals will be planned and prepared based on individual participant energy needs and dietary restrictions by a Registered Dietitian at the Georgia Clinical and Translational Science Alliance (CTSA) Bionutrition Unit located at Emory University.

Outcomes

Primary Outcome Measures

Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase
Change of the following cardiometabolic marker values will be calculated between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention): fasting lipid panel, hemoglobin A1c, basic metabolic panel (sodium, potassium, chloride, carbon dioxide (CO2), blood urea nitrogen, creatinine, and glucose), B-type natriuretic peptide (BNP), N terminal proBNP, troponin 1, mid-regional pro-adrenomedullin (MR-proADM), soluble somatostatin receptor 2 (sST2).

Secondary Outcome Measures

Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase
We will compare the change in functional exercise capacity using the American Thoracic Society 6-minute walk test between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention).

Full Information

First Posted
May 15, 2018
Last Updated
November 14, 2018
Sponsor
University of Georgia
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03538990
Brief Title
Effect of DASH Eating Pattern on Heart Failure Outcomes
Acronym
DASH HF
Official Title
Effect of Dietary Approaches to Stop Hypertension Eating Pattern on Cardiometabolic Markers in Advanced Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to examine the effect of nutritional intake on cardiometabolic, inflammation, and physical function markers in advanced heart failure patients using a one-group pre-post test design feeding trial. Effects on hemodynamic markers will be assessed in a subsample of patients with implanted hemodynamic monitoring devices (CardioMEMS). The pre-test condition is represented by participants' self-selected diet, and the post-test condition is represented by a prescribed Dietary Approaches to Stop Hypertension (DASH) diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class III
Keywords
Nutrition, Dietary Approaches to Stop Hypertension, Cardiometabolic Outcomes, Pulmonary Artery Pressure, CardioMEMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DASH Eating Pattern
Arm Type
Experimental
Arm Description
The DASH eating pattern meals prepared for study participants will strictly follow DASH meal planning guidelines published by National Heart, Lung, and Blood Institute of the National Institutes of Health. During the intervention phase of the study, all participants will exclusively consume prepared meals and provided beverages which will be delivered to participants' homes. Meals will be planned and prepared based on individual participant energy needs and dietary restrictions by a Registered Dietitian at the Georgia Clinical and Translational Science Alliance (CTSA) Bionutrition Unit located at Emory University.
Intervention Type
Other
Intervention Name(s)
DASH Eating Pattern
Intervention Description
The DASH diet is a heart-healthy eating pattern that is focused on adequate consumption of fruits, vegetables, whole grains, low-fat dairy, fish, poultry, beans, nuts, and vegetables oils while emphasizing limited intake of foods containing saturated fat, such as fatty red meats, full-fat dairy products, and tropical oils, such as coconut, palm kernel, and palm oils, as well as sugar-sweetened beverages and sweets.
Primary Outcome Measure Information:
Title
Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase
Description
Change of the following cardiometabolic marker values will be calculated between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention): fasting lipid panel, hemoglobin A1c, basic metabolic panel (sodium, potassium, chloride, carbon dioxide (CO2), blood urea nitrogen, creatinine, and glucose), B-type natriuretic peptide (BNP), N terminal proBNP, troponin 1, mid-regional pro-adrenomedullin (MR-proADM), soluble somatostatin receptor 2 (sST2).
Time Frame
Baseline, week 3, week 6
Secondary Outcome Measure Information:
Title
Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase
Description
We will compare the change in functional exercise capacity using the American Thoracic Society 6-minute walk test between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention).
Time Frame
Baseline, week 3, week 6
Other Pre-specified Outcome Measures:
Title
Change in Inflammation Marker Levels between Calibration and DASH Diet Intervention Phase
Description
We will compare the change of the following inflammation marker values between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention): interleukin (IL)-1a, IL-1b, IL-6, and tumor necrosis factor alpha (TNF-a).
Time Frame
Baseline, week 3, week 6
Title
Change in Hemodynamic Marker Levels between Calibration and DASH Diet Intervention Phase
Description
Change in mean hemodynamic marker levels will be calculated by comparing mean values from the calibration (week 1-3) and intervention phase (week 3-6). All patients will be instructed to take daily pulmonary artery pressure home readings for the duration of the study.
Time Frame
week 1-3, week 3-6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18+ years of age English language literacy Diagnosis of HF ≥ 3 months Diagnosis of NYHA Class III HF (historical assessment) Subjects must be stable on HF medication regimen for one month prior to study entry At least 1 HF hospitalization within 24 months of enrollment BNP >200 pg/ml Exclusion Criteria: Subjects who have had an unplanned HF-related hospitalization within 2 months of enrollment Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are nonresponsive to diuretic therapy or who are on chronic renal dialysis Subjects likely to undergo heart transplantation within 2 months of enrollment Subjects with severe conditions limiting 6-month survival Unavailability during scheduled data collection points Cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth L Sattler, PhD, BSPharm
Phone
706-542-1040
Email
lilian@uga.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth L Sattler, PhD, BSPharm
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia Clinical and Translational Research Unit
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Schmitz, MS
Phone
706-713-2721
Email
schmitzk@uga.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of DASH Eating Pattern on Heart Failure Outcomes

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