Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe (AMORE-Eur)
|ClinicalTrials.gov Identifier: NCT00468637|
Recruitment Status : Unknown
Verified February 2009 by University Hospital, Saarland.
Recruitment status was: Recruiting
First Posted : May 3, 2007
Last Update Posted : February 16, 2009
|Condition or disease|
|Cardiovascular High-Risk Chronic Heart Failure|
Association of cardiovascular risk factors and ED is likely due to an impairment of endothelial function resulting in a decreased activity of endothelial NO-synthase, which plays a major role in physiology of erection. Heart failure is also known to further contribute to endothelial dysfunction and hence, this could lead to erectile dysfunction.
- Evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients.
- Evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men.
- Long-term effects of cardiovascular drug therapy and cardiovascular diseases on erectile function.
Study Design Male patients across Europe with cardiovascular diseases (CHD, PAD and heart failure) will be evaluated with a standardized questionnaire. Grade of erectile dysfunction will be assessed using an ED-score, generated from two different questionnaires.
- IIEF-5 - (International Index of Erectile Function)
- KEED - (Cologne Evaluation of Erectile Dysfunction)
Primary Endpoint The primary endpoint is the sum score of the ED rating scale of the KEED (Kölner Erhebungsbogen zur Erektilen Dysfunktion, see Appendix 1). Erectile dysfunction is defined as reaching more than 17 points in the sum score.
Secondary Endpoint The first secondary endpoint is the frequency of sexual activity and sexual desire. Another secondary endpoint contains satisfaction with sex life and general well-being. Men are defined as dissatisfied by answering "mixed" or "worse".
Follow-Up: after 1 year, after 2 years.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||September 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468637
|Contact: Michael Böhm, MD||0049-6841-16- ext firstname.lastname@example.org|
|Contact: Magnus Baumhäkel, MD||0049-6841-16- ext email@example.com|
|Department of Cardiology, University Hospital of the Saarland||Recruiting|
|Homburg, Saarland, Germany, 66421|
|Contact: Magnus Baumhäkel, MD 0049-6841-16 ext 23000 firstname.lastname@example.org|
|Principal Investigator: Magnus Baumhäkel, MD|
|Sub-Investigator: Mario Kratz|
|Gemeinschaftspraxis & Ambulante Tagesklinik||Recruiting|
|Merzig-Schwemlingen, Saarland, Germany, 66663|
|Contact: Volker Rettig-Ewen, MD 0049-6861 ext 992902 email@example.com|
|Principal Investigator: Volker Rettig-Ewen, MD|
|Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia||Recruiting|
|Contact: Alberto Saporetti, MD firstname.lastname@example.org|
|Contact: Marco Metra, MD|
|Sub-Investigator: Alberto Saporetti, MD|
|Principal Investigator: Marco Metra, MD|
|Department of Cardiology, 4th Military Clinical Hospital||Recruiting|
|Contact: Ewa A Jankowska, MD email@example.com|
|Contact: Piotr Ponikowski, MD|
|Sub-Investigator: Ewa A Jankowska, MD|
|Principal Investigator: Piotr Ponikowski, MD|
|Principal Investigator:||Michael Böhm, MD||Department of Cardiology, University Hospital of the Saarland|
|Principal Investigator:||Magnus Baumhäkel, MD||Department of Cardiology, University Hospital of the Saarland|