← Back to Search

Low-Sodium, High-Quality Diet for Heart Failure Prevention

N/A
Waitlist Available
Led By Scott L. Hummel, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Veterans aged 45 years with HTN here defined as screening systolic BP 130 and/or diastolic BP 85 mmHg, or current use of anti-hypertensive drugs and metabolic syndrome body mass index 30 kg/m2 and/or waist circumference >94 cm
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 2 of study, months 1 and 6
Awards & highlights

Study Summary

This trial will test whether a low-sodium, high-quality dietary pattern can prevent HFpEF in Veterans at risk for this condition.

Who is the study for?
This trial is for Veterans aged 45+ with high blood pressure and metabolic syndrome, which includes obesity or a large waist size. They must be willing to use a smartphone app or email for the WHEELS-I program. It's not open to those with recent heart attacks, uncontrolled diabetes, severe heart conditions, very high blood pressure, certain past illnesses like HFpEF, or who are in other studies.Check my eligibility
What is being tested?
The study tests if following a special diet called DASH/SRD can prevent heart failure in people at risk. Participants will either adopt this healthy eating plan that reduces salt intake and improves overall diet quality or follow their usual diet as control for comparison.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include initial discomforts such as cravings or hunger due to new food habits. However, no significant medical side effects are expected from adopting the DASH/SRD diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran aged 45 or older with high blood pressure or on blood pressure medication, and I am overweight.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 2 of study, months 1 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 2 of study, months 1 and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Left ventricular mass index
Secondary outcome measures
Carotid-femoral pulse wave velocity
Global left atrial strain
Global longitudinal left ventricular strain
+2 more
Other outcome measures
24-hour urinary sodium excretion
Salt-sensitivity phenotype
Sodium-restricted DASH diet adherence

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Motivational Interviewing + WHEELS-IExperimental Treatment1 Intervention
In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I).
Group II: DASH/SRD DietExperimental Treatment1 Intervention
Participants in this arm will receive prepared, pre-packaged meals containing 1150mg of sodium.
Group III: Motivational InterviewingActive Control1 Intervention
Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan.
Group IV: Control DietPlacebo Group1 Intervention
Participants in this arm will receive prepared, pre-packaged meals containing 5750mg of sodium.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,515 Total Patients Enrolled
38 Trials studying Heart Failure
63,107 Patients Enrolled for Heart Failure
Scott L. Hummel, MDPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
1 Previous Clinical Trials
1,400 Total Patients Enrolled
1 Trials studying Heart Failure
1,400 Patients Enrolled for Heart Failure

Media Library

Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors Clinical Trial Eligibility Overview. Trial Name: NCT03170375 — N/A
Heart Failure Research Study Groups: Motivational Interviewing + WHEELS-I, Motivational Interviewing, DASH/SRD Diet, Control Diet
Heart Failure Clinical Trial 2023: Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors Highlights & Side Effects. Trial Name: NCT03170375 — N/A
Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors 2023 Treatment Timeline for Medical Study. Trial Name: NCT03170375 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can join the clinical trial at its maximum capacity?

"Affirmative. Per the information posted to clinicaltrials.gov, this research is currently managed and recruiting participants since it was initially launched on January 2nd 2019. 130 patients from a single medical facility are required for completion of the study."

Answered by AI

Are there still open slots for participation in this clinical experiment?

"Affirmative. The information available on clinicaltrials.gov demonstrates that this investigation is actively recruiting participants, having been posted on the 2nd of January 2019 and edited most recently on February 23rd 2022. 130 patients need to be enrolled from one specific medical centre."

Answered by AI
~0 spots leftby Mar 2024