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Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines (MEXICHO)

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ClinicalTrials.gov Identifier: NCT00885651
Recruitment Status : Unknown
Verified April 2009 by Rigshospitalet, Denmark.
Recruitment status was:  Enrolling by invitation
First Posted : April 22, 2009
Last Update Posted : April 22, 2009
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by:
Rigshospitalet, Denmark

Brief Summary:

Heart failure is a frequent disease in Denmark, and it is associated with very high mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000 hospitalizations every year due to this disease. From the time of diagnosis, patients survive an average of 4-5 years.

A critical illness mechanism in heart failure is that these patients have high blood levels of catecholamines; epinephrine and norepinephrine, which is stress hormones from the sympathetic nervous system. Standard treatment of heart failure is with the two medical preparations betablockers and ACE-inhibitors.

It is not known what effect betablocker-treatment have on blood concentration of epinephrine and norepinephrine.

It is the purpose of this study, to investigate the effect of Selo-Zok ® (metoprolol) on the blood concentration of epinephrine and norepinephrine. This is done by creating a stress condition for the body, in this case with the bicycle test, while doing blood samples to determine the concentration of catecholamines. This will be done by 1-week treatment of tablet Selo-Zok ® followed by 1-week treatment of placebo (a substance with no medical effect). Blood samples will be taken to determine small changes in inheritance material (DNA) in the form of point mutations also called single nucleotide polymorphisms, since these changes can affect how we respond to metoprolol treatment.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: Metoprolole (Selo-Zok ®) Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blinded, Crossover Study of the Influence of Metoprolol on Exercise Induced Elevation of Catecholamines in Healthy Subjects.
Study Start Date : September 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Metoprolol for 10 days followed by placebo for 7 days.
Drug: Metoprolole (Selo-Zok ®)
Tablets, 200 mg, once a day, 10 days
Drug: Placebo
Placebo Comparator: 2
Placebo for 7 days followed by Metoprolol for 10 days
Drug: Metoprolole (Selo-Zok ®)
Tablets, 200 mg, once a day, 10 days
Drug: Placebo



Primary Outcome Measures :
  1. Changes in stress-triggered response of catecholamines. [ Time Frame: 2 weeks and 3 days ]

Secondary Outcome Measures :
  1. Change in stress-triggered blood pressure response. [ Time Frame: 2 weeks and 3 days ]
  2. Change in stress-triggered pulse response. [ Time Frame: 2 weeks and 3 days ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Kaukaser
  • Healthy men
  • 18 years < age < 30 years
  • Non-smoker
  • 18 < BMI < 25
  • No chronic diseases
  • Motor-disability that disables completement of cardio-pulmonary exercise-test.

Exclusion Criteria:

  • Alcohol abuse or any other abuse
  • Intake of any narcotic drugs (example: cannabinoids, narcotics, stimulants of central nervous system, hypnotics, hallucinogenes)
  • Any of following medication:

    • astmamedication
    • heartmedication
    • antihistamines
    • antipsycotics
    • NSAIDs
    • rifampicine
    • chinidine
    • glucocorticoids
  • Abnormal ECG, particularly 2. or 3. degree AV-block, sinusbradycardia, sick sinusnode-syndrome, sign of heart failure or ischemia.
  • Allergy or intolerance of metoprolole
  • Lactoseallergy
  • 110 mmHg < Systolic blood pressure < 140 mmHg
  • 60 mmHg < Diastolic blood pressure < 90 mmHg
  • Bloodsucker > 11,1 mmol/L, or fasting, venous bloodsucker >= 7,0 (measured if: 7,8 < BS < 11,1)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885651


Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Heart Foundation
Investigators
Principal Investigator: Henrik HP Enghusen Poulsen, MD Rigshospitalet, Universityhospital of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Morten Petersen, Department of Clinical Pharmacology, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00885651     History of Changes
Other Study ID Numbers: 13-5-23-9-3-8-15
EudraCTnr. 2008-001908-23
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Keywords provided by Rigshospitalet, Denmark:
SNP
catecholamines
metoprolole
healthy subjects
physiological stress

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action