Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial
Primary result · 24-h ambulatory SBPResult — go to the resultDifference −2.4 mmHg 95% CI −4.5 to −0.3Authors' conclusion
The HERB-DH1 pivotal study showed the superiority of digital therapeutics compared with standard lifestyle modification alone to reduce 24-h ambulatory, home, and office BPs in the absence of antihypertensive medications.
Study context
- Population
- Patients with hypertension (office systolic blood pressure (SBP) 140 to <180 mmHg and 24 h SBP ≥130 mmHg) not receiving antihypertensive medication
- Participants
- 390 patients
- Comparison
- Digital therapeutics vs Control
- Digital therapeuticsn = 199
- Controln = 191reference
- Primary endpoint
- Mean change in 24 h ambulatory SBP
- Follow-up
- Baseline to 12 weeks
Methodological detailsprospective, open-label, 12 sites in Japan, Enrolment December 2019 to June 2020
- Prospective
- Open-label
- 12 sites in Japan
- Enrolment December 2019 to June 2020
Primary result
24-h ambulatory SBP · 12 weeks
Difference
−2.4 mmHg
95% CI −4.5 to −0.3
Digital therapeutics vs Control
difference −2.4 mmHg (95% CI −4.5 to −0.3)
As reported in the abstract
Secondary outcomes
| Outcome | Difference (mmHg) (95% CI) | |
|---|---|---|
| Home SBP · 12 weeks | −4.3 (−6.7 to −1.9) | |
| Office SBP · 12 weeks | −3.6 (−6.2 to −1.0) | |
| −10−505Difference, mmHg (linear scale) |
Safety
Major programme-related safety events · up to 24 weeks
- No major programme-related safety events occurred
Original publication
Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial. Eur Heart J. Published 29 August 2021. doi:10.
Summarised from the published abstract; every number is checked against it