Trial results for a study on dietary prevention of Heart Failure in hypertensive metabolic syndrome were posted on 2025-09-10. The trial reported a statistically significant p-value of 0.03 from one of its linear regression analyses.
Background
Heart failure, particularly heart failure with preserved ejection fraction (HFpEF), affects many individuals, leading to poor quality of life, frequent hospitalizations, and high death rates. Older individuals and those with high blood pressure, obesity, and metabolic syndrome are at particular risk for HFpEF. The role of dietary patterns in vulnerable 'salt-sensitive' people in the development of HFpEF has been a focus of research.
Trial design
This completed study enrolled 71 participants. The trial focused on Heart Failure, specifically exploring dietary prevention in hypertensive metabolic syndrome. The study phase was not specified. Participants were divided into groups receiving 'Motivational Interviewing + WHEELS-I' or 'Motivational Interviewing'. The primary outcomes were not explicitly listed in the trial data.
Key results
The study reported on several key measurements:
- Carotid-femoral Pulse Wave Velocity:
- For Salt-sensitive Participants, the mean change was -0.3 m/s (Standard Deviation 1.6).
- For Non Salt-sensitive Participants, the mean change was 0.4 m/s (Standard Deviation 3.0).
- In the Motivational Interviewing + WHEELS-I group, the mean change was 1.1 m/s (Standard Deviation 1.5).
- In the Motivational Interviewing group, the mean change was 0.3 m/s (Standard Deviation 1.9).
- Left Ventricular Mass Index:
- In the Motivational Interviewing + WHEELS-I group, the mean change was -3.3 g/m2 (Standard Deviation 15.5).
- In the Motivational Interviewing group, the mean change was -1.7 g/m2 (Standard Deviation 12.2).
- Global Longitudinal Left Ventricular Strain:
- For Salt-sensitive Participants, the mean change was -0.2 ratio (Standard Deviation 2.5).
- For Non-salt Sensitive Participants, the mean change was -0.5 ratio (Standard Deviation 2.0).
- Salt-sensitivity Phenotype:
- The Motivational Interviewing + WHEELS-I group included 9 Participants.
- The Motivational Interviewing group included 22 Participants.
- 24-hour Urinary Sodium Excretion:
- In the Motivational Interviewing + WHEELS-I group, the mean change was -456 mg/24h (Standard Deviation 2077).
- In the Motivational Interviewing group, the mean change was -204 mg/24h (Standard Deviation 1721).
Key analyses included:
- A linear regression analysis reported a p-value of 0.28.
- Another linear regression analysis reported a p-value of 0.6.
- A further linear regression analysis reported a p-value of 0.27.
- A linear regression analysis reported a statistically significant p-value of 0.03.
- A generalized estimating equations analysis reported a p-value of 0.47.
- Another generalized estimating equation analysis reported a p-value of 0.28.
What this means
The presence of a statistically significant p-value of 0.03 from one of the linear regression analyses suggests a notable effect within the study. While the specific outcome linked to this p-value is not explicitly stated in the analysis data, the trial explored various cardiovascular parameters, including changes in Left Ventricular Mass Index and Carotid-femoral Pulse Wave Velocity. These findings may contribute to understanding the impact of dietary interventions on cardiac health in at-risk populations, particularly those with hypertensive metabolic syndrome.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03170375, titled 'Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome', were posted on 2025-09-10 on clinicaltrials.gov.