Bisoprolol in Hypertension: Effect on Concomitant Elevated Heart Rate
The b.p.m study will be performed to gain the insight in the courses of illness and therapy in subjects, suffering from hypertension and that have elevated heart rate. This study will show that a therapy with bisoprolol (Concor/Concor PLUS) or any other blood pressure lowering (antihypertensive) drug lowers blood pressure (BP) and heart rate and increases the quality of subjects' life.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||b. p. m Study (Beats Per Minute): Heart Rate Development Whilst Treating Patients With Hypertension With Concor or Concor Plus|
- Improvement in heart rate [ Time Frame: Baseline to 6 months of therapy treatment ] [ Designated as safety issue: No ]
- Changes in systolic and diastolic BP [ Time Frame: Baseline to 6 months of therapy treatment ] [ Designated as safety issue: No ]
- Assessment of quality of life (SQ-8 Short Form Health Survey) [ Time Frame: Beginning and at the end of 6 month therapy ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Drug: Bisoprolol or bisoprolol + HCTZ
The b.p.m study measures heart rate development whilst treating subjects with hypertension with Concor [bisoprolol] or Concor Plus [bisoprolol + hydrochlorothiazide (HCTZ)].
The objectives of this study are:
After 6 months of the therapy treatment, 60% of the subjects showed a heart rate ≥ 80 beats/min.
An improved quality of life information after 6 months of therapy treatment, collected by asking standardised questions A decrease in systolic and diastolic BP after 6 months presented significant differences Digital sphygmomanometers (BP measuring devices) will be supplied in order to document the values of BP and heart rate. Blood pressure and heart rate should be measured at least 2 times, ideally 4 times per day. Furthermore, every subject will additionally receive a documentation sheet, where he/she will record the measurement data. The documentation sheet will be a part of the improvement of the quality of life; it can be removed and passed on.
Every subject will be explained how to use and handle the BP measuring device and the importance of the documentation. The assessment of the quality of life must be made at the beginning and at the end of 6 month therapy. Within the framework of the examination the attending physician will ask 8 standard questions (SQ-8 Short Form Health Survey). The questionnaire will be a part of the quality of life assessment.
The main focus of the observation is on the age group < 55 years with concomitant diseases, such as diabetes or ketohexokinase (KHK).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109043
|Merck Serono Research Site|
|Study Director:||Bernhard List||Merck Serono Austria a division of Merck Gesellschaft mbH, Austria, an affiliate of Merck KGaA, Darmstadt, Germany|