Trial results for the PACESETTER study, investigating interventions for hypertension, were posted on ClinicalTrials.gov on 2025-11-24. The analyses showed no statistically significant difference in blood pressure outcomes between the intervention and control groups, with a primary comparison yielding a p-value of 0.822.
Background
Hypertension, or high blood pressure, is a significant risk factor for cerebrovascular events such as stroke. The PACESETTER (Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor) trial aimed to assess the integration of a stroke intervention into healthcare systems, particularly in low-resource settings and for populations traditionally underrepresented in research. The goal was to enhance understanding of stroke interventions and the challenges faced in such environments.
Trial design
The PACESETTER trial was designated as Phase NA and was ultimately TERMINATED. It enrolled 120 participants and focused on conditions including Blood Pressure, Hypertension, and Mhealth. The study compared two groups: the PACESETTER group, which involved systematic electronic tracking and tailoring of a risk factor, and a Healthy Lifestyle Intervention Group. No specific primary outcomes were listed for this study.
Key results
The study reported several key measurements at 12 months:
- Proportion of Participants Achieving Systolic Blood Pressure <130 mmHg at 12 Months:
- In the PACESETTER group, 15 participants achieved this target.
- In the Healthy Lifestyle Intervention Group, 17 participants achieved this target.
- Mean Systolic Blood Pressure at 12 Months:
- The PACESETTER group had a mean of 132.5 mmHg (Standard Deviation 20.8).
- The Healthy Lifestyle Intervention Group had a mean of 134.9 mmHg (Standard Deviation 18.5).
- Mean Diastolic Blood Pressure at 12 Months:
- The PACESETTER group had a mean of 85.7 mmHg (Standard Deviation 12.8).
- The Healthy Lifestyle Intervention Group had a mean of 88 mmHg (Standard Deviation 12.1).
Key analyses revealed no statistically significant differences between the groups:
- For the proportion of participants achieving SBP <130 mmHg at 12 months, a Mixed Models Analysis showed an Odds Ratio (OR) of 0.99 (95.0% confidence interval: 0.36 to 2.72) with a p-value of 0.822. This analysis compared the PACESETTER and control arms, adjusting for baseline SBP, site, and race.
- For the mean difference in final systolic blood pressure values, a Mixed Models Analysis reported a mean difference of 2.4 (95.0% confidence interval: -7.3 to 12.1) with a p-value of 0.623.
- For the mean difference (net) in diastolic blood pressure, a Mixed Models Analysis indicated a mean difference of -0.9 (95.0% confidence interval: -7.8 to 6.0) with a p-value of 0.614. This analysis used longitudinal mixed-effects repeated-measures modeling (MMRM), adjusting for baseline BP, site, and race.
What this means
The results from the PACESETTER trial indicate that the intervention, as implemented, did not demonstrate a statistically significant advantage in blood pressure reduction compared to a healthy lifestyle intervention. The consistently high p-values across key comparisons suggest that the systematic electronic tracking and tailoring approach did not lead to superior outcomes in achieving target blood pressure levels. The termination of the trial, combined with these results, implies that the intervention's effectiveness or implementability, particularly in low-resource settings, was not established.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03401489, titled "PACESETTER: Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor", were posted on 2025-11-24 on clinicaltrials.gov.