Bisoprolol in Hypertension: Effect on Concomitant Elevated Heart Rate

This study has been completed.
Sponsor:
Collaborator:
Merck Gesellschaft mbH, Austria
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01109043
First received: April 19, 2010
Last updated: July 30, 2014
Last verified: November 2011
  Purpose

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.


Condition Intervention
Hypertension
Drug: Bisoprolol or bisoprolol + HCTZ

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 351
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bisoprolol or bisoprolol + HCTZ
    Film-coated tablets containing 5 mg or 10 mg of bisoprolol hemifumarate or film-coated tablets containing 5 mg of bisoprolol fumarate (2:1) and 12.5 mg of HCTZ were given
    Other Name: Concor or Concor Plus
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   up to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hypertensive subjects

Criteria

Inclusion Criteria:

  • Subjects with high blood pressure (BP) and tachycardia
  • Subjects with essential hypotonia, angina pectoris
  • Subjects with essential hypertonia, when a therapy with ß-blockers or diuretics is not sufficiently effective
  • Precautions to be taken in case of severe peripheral circulation disorders, diabetes (especially at the time, when blood sugar is elevated), during a strict fast, in case of metabolic acidosis, atrioventricular block (AV) block of grade I, Prinzmetal angina, additional therapy with angiotensin-converting enzyme inhibitors (ACE-inhibitors), severe coronary or cerebral sclerosis, hyperuricemia or gout and in subjects with a history of severe hypersensitive reactions or during a desensitization therapy (excessive anaphylactic reaction, attenuated adrenergic counterregulation)
  • Special precautions must be taken with the subjects that have a family history or suffered from psoriasis, during a desensitization therapy (also anamnestic subjects), other obstructive pulmonary diseases on account of the possibility of initiation or intensification of bronchoconstriction, although, due to the marked ß1-selectivity of bisoprolol, the risk is lower than with non-selective ß-receptor blockers. The subjects that have a family history or suffered from psoriasis should the take Concor Plus only after a careful assessment of risk - benefit ratio. The subjects with pheochromocytoma should take Concor Plus, as well as other ß-blockers after inhibiting the alpha-receptors

Exclusion Criteria:

  • Subjects with acute cardiac insufficiency, sinus sick syndrome, bradycardia and anaemia
  • Contraindicated medical conditions for bisoprolol as defined in the Product Information, i.e. a known hypersensitivity to the active agent bisoprolol or one of the inactive ingredients of the medication; acute heart failure or decompensation of heart insufficiency, that requires a therapy with inotropic agents; cardiogenic shock; AV block grade II or III (in the absence of cardiac pacemakers); sick sinus syndrome, sinoatrial heart block; symptomatic bradycardia; symptomatic hypotonia; severe asthma bronchiolus or severe chronic obstructive airways disease; advanced stages of peripheral arterial disease or Raynaud's Syndrome; untreated pheochromocytoma, metabolic acidosis
  • Contraindicated medical conditions for bisoprolol + hydrochlorothiazide (HCTZ) as defined in the Product Information, i.e. hypersensitivity to the ingredients of the medication containing bisoprolol + HCTZ, uncompensated heart insufficiency, pulmonary hypertension, cardiogenic shock, AV block, grades II and III. sick sinus syndrome (in the absence of cardiac pacemakers), sinoatrial heart block, severe bradycardia with less than 50 beats/min from the start of treatment, hypotension(systolic less than 90 mmHg), acute asthmatic attack, intravenous administration of calcium antagonists of Verapamil type, simultaneous treatment with monoamine oxidase inhibitors (MAO-inhibitors), advanced stages of peripheral circulation disorder, severe therapy-resistant potassium deficiency, severe hyponatraemia, hypercalcaemia, severe renal dysfunction (serum creatinin over 1.8 mg/100 ml and/or creatinin clearance under 30 ml/min); acute glomerulonephritis; liver coma; children, not previously treated; pregnancy and breastfeeding
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01109043

Locations
Austria
Merck Serono Research Site
Vienna, Austria
Sponsors and Collaborators
Merck KGaA
Merck Gesellschaft mbH, Austria
Investigators
Study Director: Bernhard List Merck Serono Austria a division of Merck Gesellschaft mbH, Austria, an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01109043     History of Changes
Other Study ID Numbers: 084000-504
Study First Received: April 19, 2010
Last Updated: July 30, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Merck KGaA:
Hypertension
Bisoprolol
Antihypertensive drugs
Blood pressure
Quality of life
Diabetes
Ketohexokinase

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Bisoprolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014