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Electronic monitoring of the use of antihypertensive drugs in patients with "drug resistant" hypertension

Electronic monitoring of the use of antihypertensive drugs in patients with "drug resistant" hypertension

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23458
Enrollment
150
Registered
2008-06-30
Start date
2006-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

drugs, blood pressure, hypertension, compliance, treatment resistance, MEMS monitors

Interventions

MEMS monitors are caps of pill boxes which record time and date of every opening of the pill box. Assuming that every opening is a single dose intake, a dosing history of a patient can be recorded dur

Sponsors

This is an investigator-driven study. Principal Investigator: prof. dr. P.W. de Leeuw Co-investigators: dr. P. Nelemans and dr. A.A. Kroon
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Eligible are patients who have drug-resistent hypertension and have no renal artery stenosis (must have been excluded by conventional renal angiography or CT angiography or MR angiography). Drug resistant hypertension is defined as having mean blood pressure >130/80 mm Hg according to 24-hour ambulatory blood pressure measurements (ABPM) despite the use of three or more drugs.

Exclusion criteria

Exclusion criteria: - Patient that do not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the proportion of patients who reach the target levels at 6 months after inclusion (question 1 and 2) and at one year after inclusion (question 3).

Secondary

MeasureTime frame
Secondary outcome measures are: - The proportion of patients with substantial decrease in blood pressure (SBP > 10 mm Hg and/or DBP > 5 mm Hg) - The compliance rate defined as percentage of days with correct number of dosing and prescribed number and doses of antihypertensive drugs.

Contacts

Public ContactA.A. Kroon

Academisch Ziekenhuis Maastricht Department of Internal Medicine

akr@sint.azm.nl+31 (0)43 3875100

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)