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

NCT ID: NCT06938633

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-07
• Study Completion Date: 2025-09-30

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.

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.

Conditions

Hypertension; Uncontrolled Hypertension; Non-Adherence, Medication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

mass spectrometry analysis

Intervention Type: OTHER

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

Interventions

mass spectrometry analysis

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Changi General Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Sumitro Harjanto, MD MRCP

Role: CONTACT

sumitro.harjanto@singhealth.com.sg

+6564267818

Geraldine Lim

Role: CONTACT

geraldine.lim.x@singhealth.com.sg

+6564267818

Facility Contacts

Sumitro Harjanto, MD MRCP

Role: primary

sumitro.harjanto@singhealth.com.sg

+65

Other Identifiers

ADURINE

Identifier Type: -

Identifier Source: org_study_id