Heart Failure Clinical Trial
Official title:
Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome
Verified date | May 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 81 |
Est. completion date | June 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Salt-sensitivity phenotype | Change in 24-hour mean of >= 8 mmHg will define the salt-sensitive blood pressure phenotype | Phase 1 of study, change from baseline at the end of week 2 and week 4 | |
Other | 24-hour urinary sodium excretion | Measure of dietary sodium intake | Phase 2 of study, change from baseline to 6 months | |
Other | Sodium-restricted DASH diet adherence | Sodium-restricted DASH diet score on Food Frequency Questionnaire, measured by complete or partial adherence to 9 dietary domains | Phase 2 of study, change from baseline to 6 months | |
Other | Sodium-restricted DASH diet adherence | Analysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research | Phase 2 of study, months 1 and 6 | |
Primary | Carotid-femoral pulse wave velocity | Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness | Phase 1 of study, change from baseline at the end of week 2 and week 4 | |
Primary | Left ventricular mass index | Left ventricular mass indexed to height | Phase 2 of study, change from baseline to 6 months | |
Secondary | Ventricular stiffness | Ventricular stiffness k, by Parametrized Diastolic Formalism analysis | Phase 1 of study, change from baseline at the end of week 2 and week 4 | |
Secondary | Global longitudinal left ventricular strain | Global longitudinal left ventricular strain, a sensitive measure of ventricular systolic function | Phase 1 of study, change from baseline at the end of week 2 and week 4 | |
Secondary | Global left atrial strain | Global left atrial strain, a novel measure of atrial function | Phase 1 of study, change from baseline at the end of week 2 and week 4 | |
Secondary | Carotid-femoral pulse wave velocity | Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness | Phase 2 of study, change from baseline to 6 months | |
Secondary | Left atrial volume | Left atrial volume by 3D echocardiography | Phase 2 of study, change from baseline to 6 months |
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