Cardiovascular Effects of Selective I(f)-Channel Blockade
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00865917|
Recruitment Status : Unknown
Verified March 2009 by Hannover Medical School.
Recruitment status was: Recruiting
First Posted : March 19, 2009
Last Update Posted : March 19, 2009
|Condition or disease||Intervention/treatment||Phase|
|Postural Orthostatic Tachycardia Syndrome||Drug: beta-blocker (Metoprolol) Drug: I(f)-blocker (ivabradine) Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Einfluss Selektiver I(f)-Blockade Auf Orthostase-Toleranz Und Sympathikusaktivität Bei Gesunden|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||December 2010|
Active Comparator: 1
Drug: beta-blocker (Metoprolol)
Metoprolol 95 mg once per day
Drug: I(f)-blocker (ivabradine)
ivabradine 7.5 mg once per day
Placebo Comparator: 3
- Sub-study 'Orthostatic tolerance': Change in heart rate after 20 mins of passive orthostasis. Sub-study 'Sympathetic system': arterial pressure related heart rate [ Time Frame: 12-18 hours ]
- 'Orthostatic tolerance': Hemodynamics during head-up tilt. Time to presyncope. [ Time Frame: 12-18 hours ]
- 'Sympathetic system': Muscle sympathetic nerve activity (MSNA). [ Time Frame: 12-18 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865917
|Contact: Heidrun Mehling, MD||+49(0)30 ext 94171296|
|Contact: Jens Tank, MD||+49(0)511 ext 532 2723|
|Franz-Volhard Centrum für Klinische Forschung||Recruiting|
|Berlin, Germany, 13125|
|Contact: Heidrun Mehling, MD +49(0)30 ext 94171296|
|Medizinische Hochschule Hannover||Recruiting|
|Hannover, Germany, 30625|
|Contact: Jens Tank, MD +49(0)30 ext 5322723|
|Contact: Karsten Heusser, MD +49(0)30 ext 5322723|
|Study Director:||Jens Jordan, MD||Hannover Medical School|