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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00885651
First received: April 20, 2009
Last updated: April 21, 2009
Last verified: April 2009
History of Changes
  Purpose

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 Intervention Phase
Heart Failure
 Drug: Metoprolole (Selo-Zok ®)
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Changes in stress-triggered response of catecholamines. [ Time Frame: 2 weeks and 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in stress-triggered blood pressure response. [ Time Frame: 2 weeks and 3 days ] [ Designated as safety issue: No ]
  • Change in stress-triggered pulse response. [ Time Frame: 2 weeks and 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885651

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

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: April 20, 2009
Last Updated: April 21, 2009
Health Authority: Denmark: GCP unit, Copenhagen University Hospital

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Metoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on June 18, 2013