Prevalence of Resistant Hypertension With DOT

NCT02513524 | Completed

• 1 other identifier: 4096
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

hypertension; adherence; resistant hypertension; blood pressure; non-adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prevalence of resistant hypertension at 1 month

  1 month

Study Arms (1)

Direct Observed Therapy test

Patients with resistant hypertension (as defined in the eligibility criteria) will be enrolled. They will all have undergone 24 hour ambulatory blood pressure monitoring (ABPM) before enrollment. As part of the study, the subjects will undergo direct observed therapy testing, followed by another 24 hour ABPM, which will be repeated at 1 month.

Procedure: Direct Observed Therapy test

Interventions

Direct Observed Therapy test PROCEDURE

There is one group only, all of whom will undergo direct observed therapy testing

Direct Observed Therapy test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is patients with resistant hypertension referred to a tertiary care hypertension clinic.

You may qualify if:

• Age 18 years or older
• 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
• Adherence to medications confirmed by patient, and by hypertension clinic on basis of pharmacy filling record

You may not qualify if:

• Pregnant patients
• Inability to provide informed consent

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H7W9, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marcel Ruzicka, MD PhD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 31, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

CA (1)