Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome

NCT03170375 | Completed Results DMC

• 2 other identifiers: CARA-009-16F9050
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

obesity; sodium; DASH diet; hypertension; vascular stiffness; diastolic function

Outcome Measures

Primary Outcomes (2)

• Carotid-femoral Pulse Wave Velocity

  Phase 1 primary hypothesis: greater reduction in carotid-femoral pulse wave velocity with DASH diet in individuals with salt-sensitive blood pressure Change in velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness

  Phase 1 of study, change between week 2 and week 4

• Left Ventricular Mass Index

  Left ventricular mass indexed to body surface area. Larger/greater left ventricular mass index is associated with increased long-term risk of cardiovascular events, including the development of heart failure. Normal values for men are 49-115 g/m² and for women 43-95 g/m²

  Phase 2 of study, change from baseline to 6 months

Secondary Outcomes (2)

• Global Longitudinal Left Ventricular Strain

  Phase 1 of study, change between week 2 to week 4

• Carotid-femoral Pulse Wave Velocity

  Phase 2 of study, change from baseline to 6 months

Other Outcomes (8)

• Salt-sensitivity Phenotype

  Phase 1 of study, change between week 2 and week 4

• 24-hour Urinary Sodium Excretion

  Phase 2 of study, change from baseline to 6 months

• Sodium-restricted DASH Diet Adherence by Food Frequency Questionnaire (FFQ)

  Phase 2 of study, change from baseline to 6 months

Study Arms (2)

Motivational Interviewing + WHEELS-I

EXPERIMENTAL

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). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.

Behavioral: Performance of WHEELS-I in promoting DASH/SRD adoption

Motivational Interviewing

ACTIVE COMPARATOR

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. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.

Behavioral: Performance of WHEELS-I in promoting DASH/SRD adoption

Interventions

Performance of WHEELS-I in promoting DASH/SRD adoption BEHAVIORAL

All participants will receive motivational interviewing (MI) based counseling. Participants in the MI + WHEELS-I arm will also receive the WHEELS-I electronically-delivered tailored messaging.

Also known as: Phase 2

Motivational Interviewing; Motivational Interviewing + WHEELS-I

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

MeSH Terms

Conditions

Heart Failure; Obesity; Hypertension

Interventions

Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

1. recruitment initially delayed 1 yr due to VA privacy/information security review for app Due to COVID-19: 2. no sublingual darkfield microscopy performed 3. lost 1.5 yrs recruitment time, had to decrease in-person visits Related to study diet: 4. Meal company changed meal offerings and no longer offered high-sodium option Due to 3) and 4) above: changed protocol to 2 weeks ad-lib diet then 2 weeks low-sodium DASH diet Due to 1) and 3) above: unable to recruit full intended cohort

Results Point of Contact

• Title: Scott Hummel
• Organization: VA Ann Arbor Health System

scott.hummel@va.gov

734-845-5283

Study Officials

• Scott L. Hummel, MD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Phase 1 of study: sequential design, 14 days each of usual diet followed by 14 days of sodium-restricted DASH diet Phase 2 of study: randomized assignment, 6 months of motivational interviewing vs. motivational interviewing plus mobile application-based promotion of dietary adherence

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: January 2, 2019
• Primary Completion: March 31, 2024
• Study Completion: January 23, 2025
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)