NCT03170375Completed
Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 71 (actual)
- First submitted
- 26 May 2017
- Start date
- 2 Jan 2019
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Heart failure, Obesity, High blood pressure
- NCT number
- NCT03170375
What you commit to
- Study type: Interventional
- Participants enrolled: 71
- From 2 Jan 2019 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous history of HF
- myocardial infarction or stroke within the prior 6 months
- unoperated aortic aneurysm for which surgery is indicated, prior hyperkalemia requiring urgent treatment
Other illness
- moderate or severe valvular heart disease
- chronic kidney disease with estimated glomerular filtration rate \<45 ml/min/ 1.73m2
- investigator-determined factors: severe pulmonary disease, e.g.:
- oxygen-requiring
- hepatic disease, e.g.:
- cirrhosis
- active cancer other than non-melanoma skin or low-risk prostate cancer
- and/or a history of persistent nonadherence to treatment
Lab values
- left ventricular ejection fraction \<50%
- hemoglobin \<9 gm/dL
- severely uncontrolled diabetes (hemoglobin A1c \>10%)
Other
- On-treatment systolic BP of \>160 mmHg at screening visit
- other comorbidity with expected survival \<12 months
- active alcohol/illicit substance abuse
- 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)
Who the study is looking for
- 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
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.