COLLATERAL BENEFITS OF PARTICIPATION IN CLINICAL RESEARCH: INSIGHTS FROM A RESISTANT HYPERTENSION TRIAL SCREEN OUT POPULATION

Abstract

Objective: Patients with resistant hypertension (HTN) were invited to take part in an ongoing randomised, double-blind, sham-controlled, multi-centre, multi-national renal denervation trial. We evaluated the benefits for patients coming into research at our centre. Design and method: Male or female patients 18–75 years old with resistant HTN were invited to participate. Post consent, clinic blood pressure (CBP) measurements were recorded. Patients also had 24-hour ambulatory BP (ABP) to exclude pseudo-resistant HTN. All patients underwent screening for secondary causes of HTN. Antihypertensive medications were changed to a fixed dose combination pill (Sevikar/HCT). Ineligible patients had medication changes as per clinical judgement to improve BP control. Repeat CBP and ABP assessments were done at 4 weeks. Results: 170 patients were assessed. The mean age was 59.6 ± 9.6 years, males (78%) and Caucasians (66%). The average number of anti-hypertensive medications was 4.1 ± 1.2. The mean CBP was 154/91mmHg, mean daytime ABP was 150/85mmHg. Following adjustments in medication after 4 weeks, the reduction in Clinic SBP was 14 ± 10 mmHg and DBP was 6.3 ± 6.2 mmHg (n = 145; p < 0.001 for both). The reduction in mean systolic daytime ABP was 8 ± 8.2 mmHg and DBP was 6 ± 7 mmHg (n = 91, p < 0.001 for both). The average number of anti-hypertensive medications reduced to 3.2 ± 1.3. Screening generated 74 new diagnoses and 34 newly detected cases of secondary hypertension (summarised below). Conclusions: High screen failure rate in studies could be considered a waste of time and resources. However, our findings demonstrate considerable collateral benefits for patients: 1. Accessing specialist care as part of the study. 2. Frequent new diagnoses and newly detected secondary HTN. 3. Medication optimisation resulting in clinically meaningful BP reduction and reduced medication burden.