STEPWISE management of uncontrolled hypertension in primary care: A cluster randomised controlled trial

Background Uncontrolled hypertension is common and a major health problem because it increases the risk of cardiovascular events. We aim to assess whether a stepwise work-up management strategy for patients with uncontrolled hypertension in primary care would result in better blood pressure control compared to usual care. Methods A pragmatic, cluster-randomised controlled trial (cRCT). General practitioners (GPs) from 22 practices (10 intervention arm; 12 usual care) recruited 106 patients aged 18-80 years who had an office blood pressure (BP) >140/90 mmHg and were prescribed three or more antihypertensive drugs from different therapeutic classes for three or more months in an adequate dose. This study was conducted between October 2018 and June 2021. The intervention was a stepwise approach comprising of (i) 24-hour blood pressure measurements, (ii) dedicated attention on intake of blood pressure raising compounds, (iii) on lifestyle and on compliance to and (iv) optimalisation of medication, and (v) referral to specialist care, when appropriate. The control group received usual care. Primary outcome was the difference in 24-hours systolic BP between intervention and usual care measured at 8 months after baseline. Results Neither 24-hour nor office systolic BP 8 months after baseline did significantly differ between intervention and usual care arm: 136.9 mmHg versus 132.6 mmHg ( p=0.15) and 146.1 mmHg versus 147.6 mmHg ( p = 0.51 ), respectively. No significant differences across groups were seen in number of prescribed BP lowering medication: 2.98 versus 3.11, or controlled hypertension after 8 months: 22% versus 28%. Conclusions Our results are compatible with the notion that a pragmatic but structured stepwise treatment of uncontrolled hypertension does not result in lower 24 hour or office BP values as compared to usual primary care. Trial registration : NTR7304 (www.trialregister.nl/trial/7099)