Prevalence of Resistant Hypertension With DOT

Hypertension Clinical Trial

— DOT  

Official title:

The Prevalence of Pseudo-resistant Hypertension Using the Direct Observed Therapy Test: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513524
• Other study ID #: 4096
• Status: Completed
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: March 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

High blood pressure is a risk factor for bad clinical events, such as heart failure, stroke, kidney failure and death. This risk is much higher in those with 'resistant' hypertension, in whom the blood pressure remains high despite more than 3 blood pressure medicines. Current estimates of the proportion of individuals with resistant hypertension may be an overestimate, since some of them are not actually adherent (i.e. not taking the medicines they are prescribed). Methods to detect non-adherence, such as asking the patient, counting pills, and getting records from pharmacy are not fool proof. Direct observed therapy (where patients are administered medicines under observation by a health care personnel) is quite useful to diagnose this, and is the standard of care in the Renal Hypertension Clinic, before more tests and interventions (such as CT scans, renal angiogram) are performed.

In this study, the investigators will measure the proportion of patients with resistant hypertension who are non-adherent based on direct observed therapy, and follow them up to examine the impact of this diagnosis.

Description:

This is a prospective, observational study.

Patients fitting inclusion and exclusion criteria, after informed consent, will undergo the direct observed therapy test in the hypertension unit (this is usual care in the unit, which they will undergo even if they are not part of the study).

The Direct Observation Therapy (DOT) Test includes the following components:

1. Administer and observe ingestion of usual morning antihypertensive medications.

2. Monitor BP every 30 minutes, using 5 readings of an automated oscillometric BP device ( BP-TRU), until plateau affect achieved, defined as 3 consecutive cycles of BP readings declining by less than 10 mmHg per cycle).

3. Registered Nurse (RN) repeats standing BP prior to initiation of 24 hour Ambulatory Blood Pressure Monitoring(ABPM).

4. RN initiates 24 hour ABPM

In addition, participants will undergo an additional 24-hour ABPM test 1 month after the DOT test is undertaken.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older

2. Confirmed resistant hypertension defined as daytime BP readings above 135/85 mmHg (confirmed by 24-hour ABPM results) using 3 or more BP lowering drugs

3. Adherence to medications confirmed by patient, and by hypertension clinic on basis of pharmacy filling record

Exclusion Criteria:

1. Pregnant patients

2. Inability to provide informed consent

Related Conditions & MeSH terms

• Hypertension

Intervention

Procedure:
• Direct Observed Therapy test
There is one group only, all of whom will undergo direct observed therapy testing

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of true resistant hypertension	The proportion of patients who continue to have resistant hypertension after administration of direct observed therapy, on the basis of the 24 hour ambulatory testing	1 week
Secondary	Prevalence of resistant hypertension at 1 month	The proportion of patients who continue to have resistant hypertension at one month, on the basis of the 24 hour ambulatory testing	1 month