Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines (MEXICHO)
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metoprolole (Selo-Zok ®)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring SNP, catecholamines, metoprolole, healthy subjects, physiological stress
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Metoprolol for 10 days followed by placebo for 7 days.
Placebo for 7 days followed by Metoprolol for 10 days
Outcomes
Primary Outcome Measures
Changes in stress-triggered response of catecholamines.
Secondary Outcome Measures
Change in stress-triggered blood pressure response.
Change in stress-triggered pulse response.
Full Information
NCT ID
NCT00885651
First Posted
April 20, 2009
Last Updated
April 21, 2009
Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00885651
Brief Title
Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines
Acronym
MEXICHO
Official Title
A Randomised, Double Blinded, Crossover Study of the Influence of Metoprolol on Exercise Induced Elevation of Catecholamines in Healthy Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Heart Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
SNP, catecholamines, metoprolole, healthy subjects, physiological stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Metoprolol for 10 days followed by placebo for 7 days.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo for 7 days followed by Metoprolol for 10 days
Intervention Type
Drug
Intervention Name(s)
Metoprolole (Selo-Zok ®)
Intervention Description
Tablets, 200 mg, once a day, 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Changes in stress-triggered response of catecholamines.
Time Frame
2 weeks and 3 days
Secondary Outcome Measure Information:
Title
Change in stress-triggered blood pressure response.
Time Frame
2 weeks and 3 days
Title
Change in stress-triggered pulse response.
Time Frame
2 weeks and 3 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik HP Enghusen Poulsen, MD
Organizational Affiliation
Rigshospitalet, Universityhospital of Copenhagen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22703382
Citation
Petersen M, Andersen JT, Jimenez-Solem E, Broedbaek K, Hjelvang BR, Henriksen T, Frandsen E, Forman JL, Torp-Pedersen C, Kober L, Poulsen HE. Effect of the Arg389Gly beta(1)-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.
Results Reference
derived
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Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines
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