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NCT Number: NCT06938633

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

* 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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore

Location status: Recruiting

Location contact

Sumitro Harjanto, MD MRCP

CONTACT

[email protected]

+65

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

mass spectrometry analysis

Other

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

Primary outcomes

  1. Change in adherence rate

    Time frame: 6 months

    This is the difference in the adherence rates at enrollment and at the end of the study

  2. The change in systolic blood pressure

    Time frame: 6 months

    This is the difference in systolic blood pressure between enrollment and the last follow up visit at 6 months

  3. The change in diastolic blood pressure

    Time frame: 6 months

    This is the difference in diastolic blood pressure between enrollment and the last follow up visit at 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Geraldine Lim

CONTACT

[email protected]

+6564267818

Sumitro Harjanto, MD MRCP

CONTACT

[email protected]

+6564267818

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Acronym: ADURINE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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