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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
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The study compares three treatment modalities in a human model of Postural orthostatic tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.
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 but also contractility, which might be undesirable in certain tachycardic disorders.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | beta-blocker |
|
| 2 | Experimental | I(f)-blocker |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beta-blocker (Metoprolol) | Drug | Metoprolol 95 mg once per day |
| |
| I(f)-blocker (ivabradine) |
| Measure | Description | Time Frame |
|---|---|---|
| Sub-study 'Orthostatic tolerance': Change in heart rate after 20 mins of passive orthostasis. Sub-study 'Sympathetic system': arterial pressure related heart rate | 12-18 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 'Orthostatic tolerance': Hemodynamics during head-up tilt. Time to presyncope. | 12-18 hours | |
| 'Sympathetic system': Muscle sympathetic nerve activity (MSNA). | 12-18 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidrun Mehling, MD | Contact | +49(0)30 | 94171296 | |
| Jens Tank, MD | Contact | +49(0)511 | 532 2723 |
| Name | Affiliation | Role |
|---|---|---|
| Jens Jordan, MD | Hannover Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franz-Volhard Centrum für Klinische Forschung | Recruiting | Berlin | 13125 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26764413 | Derived | 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. | |
| 23434314 |
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000319 | Adrenergic beta-Antagonists |
| D008790 | Metoprolol |
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| Drug |
ivabradine 7.5 mg once per day |
|
| Placebo | Drug | matching appearance |
|
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
|
| 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. |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |