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Sponsors and Collaborators: |
University Hospital, Saarland Pfizer |
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Information provided by: | University Hospital, Saarland |
ClinicalTrials.gov Identifier: | NCT00468637 |
The purpose of the study is to evaluate the influence of cardiovascular risk factors, heart failure and cardiovascular drug therapy on erectile function in cardiovascular high-risk patients.
Condition |
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Cardiovascular High-Risk Chronic Heart Failure |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe |
Estimated Enrollment: | 1200 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | September 2011 |
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.
Study Objectives
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
primary care clinic, outpatient department, general practitioner
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Böhm, MD | 0049-6841-16- ext 23000 | michael.boehm@uniklinikum-saarland.de |
Contact: Magnus Baumhäkel, MD | 0049-6841-16- ext 23000 | magnus@baumhaekel.de |
Germany, Saarland | |
Department of Cardiology, University Hospital of the Saarland | Recruiting |
Homburg, Saarland, Germany, 66421 | |
Contact: Magnus Baumhäkel, MD 0049-6841-16 ext 23000 magnus@baumhaekel.de | |
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 praxis@rettig-ewen.de | |
Principal Investigator: Volker Rettig-Ewen, MD | |
Italy | |
Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia | Recruiting |
Brescia, Italy | |
Contact: Alberto Saporetti, MD alberto@funkgogh.it | |
Contact: Marco Metra, MD | |
Sub-Investigator: Alberto Saporetti, MD | |
Principal Investigator: Marco Metra, MD | |
Poland | |
Department of Cardiology, 4th Military Clinical Hospital | Recruiting |
Wroclaw, Poland | |
Contact: Ewa A Jankowska, MD ewa@antro.pan.wroc.pl | |
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 |
Responsible Party: | Department of Cardiology, University Hospital of the Saarland ( Dr. Magnus Baumhäkel ) |
Study ID Numbers: | 133/04 |
Study First Received: | May 2, 2007 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00468637 History of Changes |
Health Authority: | Germany: Ethics Commission |
heart failure cardiovascular high risk erectile dysfunction cardiovascular disease |
Heart Failure Heart Diseases Erectile Dysfunction |
Heart Failure Heart Diseases Cardiovascular Diseases |