STEPWISE treatment of uncontrolled HyperTensioN in primary care: a cluster randomised trial.

Completed

Conditions: high bloodpressure not responding to medication
therapieresistant hypertension
10057166

Registration Number: NL-OMON50648

Lead Sponsor: Julius Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

Patients aged > 18 years and < 80 years with an office blood pressure > 140/90
mmHg, on at least two blood pressure measurements per visit and on at least two
occasions in the last year despite prescription of three or more blood pressure
lowering drugs of different classes at adequate dosage, with for each
antihypertensive drug at least 1 prescription of 3 months. During the inclusion
consultation, the office blood pressure should be > 140/90 mmHg (measured
according to the guideline on *standardized office blood pressure measurement
based on the NHG CVRM guideline).

Exclusion Criteria

- A short life expectancy (< 6 months) as judged by the GP.
- Inability to understand or conform to the stepwise protocol.
- Unwillingness to provide a written informed consent.
- In case of suspicion of a hypertensive crisis (systolic blood pressure * 200
mmHg and/or diastolic blood pressure * 120 mmHg) the patient is referred for
further evaluation. If a hypertensive crisis is excluded, the patient can be
included in the study.
- Atrial fibrillation (because of difficulties to interpret 24 hour BP
measurements)
- Pregnancy or breast feeding.
- Severe co-morbidity, which seriously interferes with diagnostic procedures or
possible treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> The primary outcome is difference in 24-hour systolic BP between groups at 8<br /><br>months follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The percentage of patients with an office BP * 140/90 or a mean 24-hour<br /><br>BP 130/80 mmHg, measured at the endpoint (8 months).<br /><br>- The time window (time from baseline) to reach a controlled BP during<br /><br>the study, defined as twice an office BP of 140/90 mmHg, or a mean 24-hours BP<br /><br>of *130/80 mmHg.<br /><br>- The number and/or dosage needed of BP lowering drugs, measured during<br /><br>the study time.<br /><br>- Referral to the medical specialist during the study time.<br /><br>- Health care use and associated costs during the study period or bp<br /><br>control/bp related events.<br /><br>- Quality of life as measured with the EQ5D and EQ-VAS at baseline and at<br /><br>the endpoint (8 months).<br /><br>- Cost-effectiveness of the intervention expressed in terms of cost per<br /><br>patient reaching adequate BP level and cost per Quality Adjusted Life Year<br /><br>Gained.<br /><br>- Self-reported BMI </p><br>