Status:
UNKNOWN
Cardiovascular Effects of Selective I(f)-Channel Blockade
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Charite University, Berlin, Germany
Conditions:
Postural Orthostatic Tachycardia Syndrome
Eligibility:
MALE
18-40 years
Phase:
PHASE2
Brief Summary
The study compares three treatment modalities in a human model of Postural orthostatic tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.
Detailed Description
Elevated heart rate may lead to cardiac disease in the long-term. Therefore, drugs lowering heart rate are useful. Beta-blockers are an established treatment modality. They not only lower heart rate b...
Eligibility Criteria
Inclusion
- healthy male
- age 18-40 years
- BMI: 18-30 kg/m²
- arterial blood pressure \<=160/100 mm Hg
- co-operativity
- voluntariness
Exclusion
- conditions in which treatment might be ineffective or insecure
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00865917
Start Date
November 1 2008
End Date
December 1 2010
Last Update
March 19 2009
Active Locations (2)
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1
Franz-Volhard Centrum für Klinische Forschung
Berlin, Germany, 13125
2
Medizinische Hochschule Hannover
Hanover, Germany, 30625