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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

Tracking Information
First Submitted Date  ICMJE April 20, 2009
First Posted Date  ICMJE April 22, 2009
Last Update Posted Date April 22, 2009
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
Changes in stress-triggered response of catecholamines. [ Time Frame: 2 weeks and 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
  • Change in stress-triggered blood pressure response. [ Time Frame: 2 weeks and 3 days ]
  • Change in stress-triggered pulse response. [ Time Frame: 2 weeks and 3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines
Official Title  ICMJE A Randomised, Double Blinded, Crossover Study of the Influence of Metoprolol on Exercise Induced Elevation of Catecholamines in Healthy Subjects.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: Metoprolole (Selo-Zok ®)
    Tablets, 200 mg, once a day, 10 days
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 1
    Metoprolol for 10 days followed by placebo for 7 days.
    Interventions:
    • Drug: Metoprolole (Selo-Zok ®)
    • Drug: Placebo
  • Placebo Comparator: 2
    Placebo for 7 days followed by Metoprolol for 10 days
    Interventions:
    • Drug: Metoprolole (Selo-Zok ®)
    • Drug: Placebo
Publications * Petersen M, Andersen JT, Jimenez-Solem E, Broedbaek K, Hjelvang BR, Henriksen T, Frandsen E, Forman JL, Torp-Pedersen C, Køber L, Poulsen HE. Effect of the Arg389Gly β₁-adrenoceptor polymorphism on plasma renin activity and heart rate, and the genotype-dependent response to metoprolol treatment. Clin Exp Pharmacol Physiol. 2012 Sep;39(9):779-85. doi: 10.1111/j.1440-1681.2012.05736.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 21, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00885651
Other Study ID Numbers  ICMJE 13-5-23-9-3-8-15
EudraCTnr. 2008-001908-23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Morten Petersen, Department of Clinical Pharmacology, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Danish Heart Foundation
Investigators  ICMJE
Principal Investigator: Henrik HP Enghusen Poulsen, MD Rigshospitalet, Universityhospital of Copenhagen
PRS Account Rigshospitalet, Denmark
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP