Orthostatic intolerance means the defective adaptation of the cardiovascular system to the upright position. One of the major Form of this disorder, the postural orthostatic tachycardia syndrome (or POTS), is characterized by an intense increase of the heart rate at upright position without a drop in blood pressure. Patients complain of lightheadedness, fatigue or nausea at upright posture.
Conditions
Interventions
Trade Name: Edronax
Product Name: Reboxetin
Pharmaceutical Form: Tablet
INN or Proposed INN: Reboxetin
CAS Number: 98769-81-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • male subject aged 18-40 years • body mass index: 18-30 kg/m² • blood pressure =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • any diseases or functional impairments which in the investigators opinion should exclude the patient from participating in the clinical trial, e .g. evidence that the study medication could be ineffetive or unsave • intake of non-authorized concomitant medication within 4 weeks prior to study entry • Participation in another clinical trial within the 4 weeks prior to study entry • legal incompetence or other circumstances which do not allow the subject to fully understand the character, relevance and importance of the clinical trial • history of alcohol or drug abuse, or both • known or assumed secundary hypertension, e. g. pheochromocytoma • medical history of known or current functional disorders of the kidney (serum creatinine > 130 µM or 1.47 mg/dl) or liver (GOT/GPT > 2 times the ULN, GGT > 3 times the ULN) For the part ‚orthostatic tolerance’: o because of a restriciton on use for Reboxetin: hypertension, seizure disorder, urinary retention, glaucoma, attempted suicide, allergic diathesis; incompatibility against Reboxetin o because of a restriciton on use for Metoprolol: asthma bronchiale, psoriasis • Diabetes mellitus (Diabetes mellitus as defined by the ADA/WHO/DDG: two fasting glucose measurements above 126 mg/dL (7.0 mmol/l) is considered diagnostic for diabetes mellitus. Fasting is defined as abstinence from food for at least 8 hours.) • heart insufficiency NYHA stage III and IV • coronary heart disease • peripheral arterial occlusive disease (PAOD) • known cerebrovascular diseases (transient ischemic attack , ischemic or hemorrhagic insult) • ventricular extrasystole (Lown III-V), absolute arrhythmia at atrial fibrillation or atrial flutter • resting heart rate <60/min (Contraindication for Ivabradin) • for orthostatic part: resting heart rate <55/min • contraindications against the study drugs • relevant neurological or psychiatric dieseases (bipolare disorders, depressions, schizophrenia, Gilles de la Tourette-Syndrom, psychosis) • anamnestic benign hyperplasia of the prostate with retention of urine • known primary or secondary pulmonary hypertension • Dysthyreosis, viz. hyper- or hypothyreosis (patients with stable intake of thyroid hormones for at least 6 month and an euthyroid metabolism can be included in the clinical trial • subjects for whom there is concern about compliance with the protocol procedures • persons who are detained officially or legally to an official institute (according to AMG § 40 (1) 4)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ‚Orthostatic tolerance’ part: change in the heart rate at upright position after 20 min of passive orthostatism. ‚Sympathicus’ part: heart rate at given blood pressure (= standardised point on the parasympathetic baroreflex curve). The measurements are carried out in horizontal Position under rest.;Secondary Objective: ‚Orthostatic tolerance' part: • duration of the passive orthostatic load until the appearance of a presyncope • minimum heart rate during a presyncope • minimum blood pressure during a presyncope • hemodynamics (stroke volume, cardiac output , peripheral resistance) on the tilting table. ‚Sympathicus’ part: • hemodynamics (stroke volume, cardiac output, peripheral resistance) and sympathetic activity at rest and their changes during cardiovascular tests • cardiac and sympathetic baroreflex sensitivity • sensitivity of the blood pressure to the vasoactive agents sodium nitroprusside and phenylephrine • concentration or activities of hormones regulating the cardiovascular system;Primary end point(s): ‚Orthostatic tolerance’ part: change in the heart rate at upright position after 20 min of passive orthostatism. ‚Sympathetic’ part: heart rate at given blood pressure (= standardised point on the parasympathetic baroreflex curves). The measurements are carried out in horizontal Position under rest. | — |
Countries
Germany
Outcome results
None listed