Cardiovascular Effects of Selective I(f)-Channel Blockade

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study compares three treatment modalities in a human model of Postural orthostatic tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hannover Medical School
• Collaborator: Charite University, Berlin, Germany
• Treatments: Adrenergic beta-Antagonists; Metoprolol

Criteria

Inclusion Criteria:

• healthy male

• age 18-40 years

• BMI: 18-30 kg/m²

• arterial blood pressure <=160/100 mm Hg

• co-operativity

• voluntariness

Exclusion Criteria:

• 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