Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome (NCT03170375) | Clinical Trial Compass
CompletedNot Applicable
Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome
United States71 participantsStarted 2019-01-02
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<50%
* moderate or severe valvular heart disease
* myocardial infarction or stroke within the prior 6 months
* chronic kidney disease with estimated glomerular filtration rate \<45 ml/min/ 1.73m2
* unoperated aortic aneurysm for which surgery is indicated, prior hyperkalemia requiring urgent treatment
* hemoglobin \<9 gm/dL
* investigator-determined factors: severe pulmonary disease, e.g.:
* oxygen-requiring
* hepatic disease, e.g.:
* cirrhosis
* severely uncontrolled diabetes (hemoglobin A1c \>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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Carotid-femoral Pulse Wave Velocity
Timeframe: Phase 1 of study, change between week 2 and week 4
2
Left Ventricular Mass Index
Timeframe: Phase 2 of study, change from baseline to 6 months