MEXICHO: Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Unknown status

CT.gov ID

NCT00885651

Collaborator

Danish Heart Foundation (Other)

Enrollment

Arms

Duration (Months)

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2008

Anticipated Primary Completion Date :

Aug 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in stress-triggered response of catecholamines. [2 weeks and 3 days]

Secondary Outcome Measures

Change in stress-triggered blood pressure response. [2 weeks and 3 days]
Change in stress-triggered pulse response. [2 weeks and 3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)