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Stepwise treatment of uncontrolled HyperTensioN (Stepwise-HTN): Study design of a cluster randomised controlled trial
Birsen Kiliç1, Marion C J Biermans2, Frans H Rutten1
1Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Utrecht University, Utrecht, the Netherlands.
Insights
A guided stepwise approach improved blood pressure control in patients with uncontrolled hypertension in primary care compared to usual care. This strategy enhances cardiovascular disease management in general practice.
Area of Science:
- Cardiology
- Primary Care Medicine
- Clinical Trials
Background:
- Uncontrolled hypertension is a significant global health issue and a primary risk factor for cardiovascular disease.
- Despite detection and management in primary care, approximately 50% of hypertension cases remain uncontrolled.
- Effective strategies are needed to improve blood pressure control in primary care settings.
Purpose of the Study:
- To evaluate the efficacy of a guided stepwise work-up and management strategy for uncontrolled hypertension in primary care.
- To compare the effectiveness of this strategy against usual care in improving blood pressure control.
- To assess the potential for implementing an improved management strategy in routine cardiovascular risk management.
Main Methods:
- A cluster randomized controlled trial involving 40 general practices.
- Intervention group received a protocolized stepwise work-up for uncontrolled hypertension (defined as office BP >140/90 mmHg despite multiple medications).
- Control group received usual care; primary outcome was the difference in 24-h systolic blood pressure after 8 months.
Main Results:
- The study aimed to assess the difference in mean 24-h systolic blood pressure between the intervention and control groups.
- Secondary outcomes included the percentage of patients achieving controlled blood pressure and the time taken to reach control.
- Results are pending based on the trial's primary and secondary outcome measures.
Conclusions:
- If the stepwise treatment proves effective, it can be integrated into existing cardiovascular risk management programs in primary care.
- This approach offers a structured method to optimize antihypertensive treatment and improve patient outcomes.
- The findings could guide clinical practice for managing difficult-to-control hypertension.
Background:
Uncontrolled hypertension is a major health problem, and a key risk factor for cardiovascular disease. Most patients are detected and managed in primary care, but approximately 50% remains uncontrolled. Our aim is to assess whether a guided stepwise work-up management strategy for patients with uncontrolled hypertension in primary care would result in better blood pressure control in these patients compared to usual care.
Methods:
A cluster randomised controlled trial aiming at randomizing 40 general practices to either "a protocolised stepwise work-up" or to "usual care". Uncontrolled hypertension is defined as an office blood pressure (BP) >140/90 mmHg while being prescribed three or more antihypertensive drugs simultaneously from different therapeutic classes for three or more months in an adequate dose. In the intervention arm, patients with uncontrolled hypertension will receive the stepwise approach, consisting of (i) excluding a white coat effect, (ii) re-evaluation of lifestyle, (iii) re-evaluation of drug adherence, (iv) optimalisation of antihypertensive treatment and (v) referral if the office BP is still >140/90 mmHg. The control group receives usual care in a regular program for cardiovascular risk management. The primary outcome is the absolute difference in the mean 24-h systolic BP between intervention and control arm after 8 months. Secondary outcomes include differences in the percentage of patients achieving a controlled BP, and time to reach a controlled BP.
Conclusion:
If stepwise treatment of uncontrolled hypertension is proven effective, the strategy could be implemented by blending the approach to the cardiovascular risk management already applied in general practice. Trial registration NTR7304, https://www.trialregister.nl/trial/7099.
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