N/A
N=71
Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03170375 ↗Enrolled (actual)
71
Serious AEs
4.6%
Results posted
Sep 2025
Primary outcome: Primary: Carotid-femoral Pulse Wave Velocity — -0.3; 0.4 m/s — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Performance of WHEELS-I in promoting DASH/SRD adoption (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Carotid-femoral Pulse Wave Velocity |
1.1; 0.3 | 0.03 sig |
| PRIMARY Left Ventricular Mass Index |
-3.3; -1.7 | 0.60 |
| SECONDARY Global Longitudinal Left Ventricular Strain |
-0.2; -0.5 | 0.27 |
| SECONDARY Carotid-femoral Pulse Wave Velocity |
1.1; 0.3 | 0.03 sig |
Summary
Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.
Eligibility Criteria
Inclusion Criteria
- 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
- Participants must also be willing to participate in the WHEELS-I program by using a smartphone application or email
Exclusion Criteria
- On-treatment systolic BP of >160 mmHg at screening visit
- previous history of HF
- left ventricular ejection fraction 10%)
- active cancer other than non-melanoma skin or low-risk prostate cancer
- other comorbidity with expected survival <12 months
- active alcohol/illicit substance abuse
- and/or a history of persistent nonadherence to treatment
- Veterans involved in another study (unless it is survey-only and the other investigator will allow us to invite the person in a survey-only study to consider our study)
Data sourced from ClinicalTrials.gov (NCT03170375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.