Cardiovascular Effects of Selective I(f)-Channel Blockade
NCT ID: NCT00865917
Last Updated: 2009-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2008-11-30
2010-12-31
Brief Summary
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Detailed Description
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Postural orthostatic tachycardia syndrome (POTS) patients complain about dizziness, weakness, headache, lightheadedness, fatigue, nausea, and presyncope. In some patients there is elevated heart rate even during supine rest. In POTS patients it is preferable to lower heart rate without reducing cardiac contractility which can be achieved by using so-called I(f)-blockers. Thus, they might be superior to beta-blockers in POTS.
In our study, we artificially generate POTS in healthy male subjects for about 48 hours. We want to compare the cardiovascular effects and orthostatic tolerance of the following treatments: beta-blocker, I(f)-blocker, and placebo.
Moreover, we will quantify changes in cardiovascular autonomic regulation brought about by I(f)-blockade versus placebo.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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1
beta-blocker
beta-blocker (Metoprolol)
Metoprolol 95 mg once per day
2
I(f)-blocker
I(f)-blocker (ivabradine)
ivabradine 7.5 mg once per day
3
Placebo
Placebo
matching appearance
Interventions
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beta-blocker (Metoprolol)
Metoprolol 95 mg once per day
I(f)-blocker (ivabradine)
ivabradine 7.5 mg once per day
Placebo
matching appearance
Eligibility Criteria
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Inclusion Criteria
* age 18-40 years
* BMI: 18-30 kg/m²
* arterial blood pressure \<=160/100 mm Hg
* co-operativity
* voluntariness
Exclusion Criteria
* co-medication within the last 4 weeks
* participation in another clinical trial within the last 4 weeks
* unability to understand the study's aim
* drug or alcohol abuse
* secondary hypertension
* creatinine \> 130 μM (1.47 mg/dl)
* GOT/GPT \> 2 times normal
* GGT \> 3 times normal
* contraindications against reboxetine, beta-blocker, ivabradine
* asthma, psoriasis
* diabetes
* heart failure (NYHA III or IV)
* coronary artery disease
* peripheral occlusive disease
* cerebrovascular disease
* ventricular extrasystoles (Lown III-V)
* atrial fibrillation
* resting heart rate \<60/min
* neurologic/psychiatric disorder
* pulmonary hypertension
* dysthyroid metabolism
18 Years
40 Years
MALE
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
Hannover Medical School
OTHER
Responsible Party
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Franz-Volhard-Centrum für Klinische Forschung
Principal Investigators
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Jens Jordan, MD
Role: STUDY_DIRECTOR
Hannover Medical School
Locations
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Franz-Volhard Centrum für Klinische Forschung
Berlin, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Countries
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Central Contacts
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Heidrun Mehling, MD
Role: CONTACT
Jens Tank, MD
Role: CONTACT
Facility Contacts
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Heidrun Mehling, MD
Role: primary
Jens Tank, MD
Role: primary
Karsten Heusser, MD
Role: backup
References
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Heusser K, Tank J, Brinkmann J, Schroeder C, May M, Grosshennig A, Wenzel D, Diedrich A, Sweep FC, Mehling H, Luft FC, Jordan J. Preserved Autonomic Cardiovascular Regulation With Cardiac Pacemaker Inhibition: A Crossover Trial Using High-Fidelity Cardiovascular Phenotyping. J Am Heart Assoc. 2016 Jan 13;5(1):e002674. doi: 10.1161/JAHA.115.002674.
Zoerner AA, Schroeder C, Kayacelebi AA, Suchy MT, Gutzki FM, Stichtenoth DO, Tank J, Jordan J, Tsikas D. A validated, rapid UPLC-MS/MS method for simultaneous ivabradine, reboxetine, and metoprolol analysis in human plasma and its application to clinical trial samples. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 May 15;927:105-11. doi: 10.1016/j.jchromb.2013.01.016. Epub 2013 Jan 29.
Other Identifiers
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CCB-CRC-07-02
Identifier Type: -
Identifier Source: org_study_id
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