Addressing Medication Non-adherence in Patients With Poorly Controlled Hypertension Using Urine Mass Spectrometry (ADURINE)

Utility of Urine Mass Spectrometry Analysis in Addressing Medication Non-adherence in Patients With Poorly Controlled Hypertension

• Hypertension is the single largest contributor to cardiovascular disease and death. While adequate control of hypertension reduces risk of disease, many patients have uncontrolled hypertension. This is often due to medication non-adherence. Left undetected, patients are prescribed additional medications, and referred to multiple specialists for investigations - leading to increased healthcare costs. Hence, detecting non-adherence to antihypertensive medications is important. However, patient history, patient recall, or questionnaires, are often inaccurate. Most recently, urine measurements of antihypertensive drug levels, using mass spectrometry, has been established as the gold standard to assess medication adherence. The one-time urine test for medication adherence is ideal: It's convenient, non-invasive, economical, and can be easily performed in a clinic setting. By improving blood pressure control, this will lead to reductions in healthcare visits, avoidance of catastrophic cardiovascular events. Ultimately, this translates to significant economic savings for both patients with hypertension and the healthcare system.
• Therefore, the investigators hypothesize that the implementation of urine adherence testing coupled with targeted counselling will improve the adherence and blood pressure control in hypertension. To do this, the investigators aim to (1) evaluate for medication adherence in 312 participants with recent stroke and hypertension; (2) evaluate for medication non-adherence in participants with uncontrolled hypertension; and (3) assess if detection of non-adherence can improve hypertension control.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Uncontrolled Hypertension; Non-Adherence, Medication
• Intervention / Treatment: Other: mass spectrometry analysis

Detailed Description

• The investigators plan to achieve these aims in three steps. First, the investigators retrospectively assess medication adherence in 200 participants admitted for recent stroke using urine biospecimens collected. Second, the investigators will prospectively recruit 100 participants with poorly controlled hypertension and assess for medication adherence. Finally, participants detected with non-adherence will be counselled. These participants will be reassessed for improvements in both medication adherence and blood pressure.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sumitro Harjanto, MD MRCP; Phone Number: +6564267818; Email: sumitro.harjanto@singhealth.com.sg
• Study Contact Backup: Name: Geraldine Lim; Phone Number: +6564267818; Email: geraldine.lim.x@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Changi General Hospital
    • Contact: Sumitro Harjanto, MD MRCP; Phone Number: +65; Email: sumitro.harjanto@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age of 21 - 80 years
2. Systolic blood pressure of ≥140 mmHg or average systolic blood pressure ≥135 mmHg, or diastolic blood pressure ≥90 mmHg or average diastolic blood pressure ≥85 mmHg, on at least two measurements
3. Currently taking 2 or more hypertension medications
4. Able to provide informed consent.

Exclusion Criteria:

• Significant kidney impairment with eGFR of less than 45mL/min/1.73m2 or on dialysis
• Known history of chronic liver disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mass spectrometry analysis; All patients will be collected 50mls of urine for mass spectrometry analysis to determine medication adherence during each study visit; on enrolment, at 3-month, and at 6-month period.	Other: mass spectrometry analysis; The collected urine samples will be analyzed to determine medication adherence during study visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adherence rate	This is the difference in the adherence rates at enrollment and at the end of the study	6 months
The change in systolic blood pressure	This is the difference in systolic blood pressure between enrollment and the last follow up visit at 6 months	6 months
The change in diastolic blood pressure	This is the difference in diastolic blood pressure between enrollment and the last follow up visit at 6 months	6 months

Collaborators and Investigators

• Sponsor: Changi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Uncontrolled hypertension; Medication non-adherence; Urine mass spectrometry
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: ADURINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No