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

NCT06938633 | Recruiting DMC

• 1 other identifier: ADURINE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Hypertension; Uncontrolled Hypertension; Non-Adherence, Medication

Keywords

Urine mass spectrometry; Uncontrolled hypertension; Medication non-adherence

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

mass spectrometry analysis

EXPERIMENTAL

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

Interventions

mass spectrometry analysis OTHER

The collected urine samples will be analyzed to determine medication adherence during study visits

mass spectrometry analysis

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 21 - 80 years
• 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
• Currently taking 2 or more hypertension medications
• Able to provide informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Hypertension; Medication Adherence

Interventions

Gas Chromatography-Mass Spectrometry

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Chromatography, Gas; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques; Mass Spectrometry

Central Study Contacts

Sumitro Harjanto, MD MRCP

CONTACT

+6564267818; sumitro.harjanto@singhealth.com.sg

Geraldine Lim

CONTACT

+6564267818; geraldine.lim.x@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: April 22, 2025
• Study Start: February 7, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)