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Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe (AMORE-Eur)

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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
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Hospital, Saarland

Brief Summary:
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 or disease
Cardiovascular High-Risk Chronic Heart Failure

Detailed Description:

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

  1. Evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients.
  2. Evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men.
  3. 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.

  1. IIEF-5 - (International Index of Erectile Function)
  2. 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
Time Perspective: Prospective
Official Title: Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
Study Start Date : May 2007
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic, outpatient department, general practitioner
Criteria

Inclusion Criteria:

  • Male patients with two or more cardiovascular risk factors or
  • Male patients with a manifestation of atherosclerosis or
  • Male patients with an ischemic or dilated cardiomyopathy
  • Written informed consent

Exclusion Criteria:

  • Impairment of hormonal status
  • Refusal of written informed consent
  • Inability to complete the questionnaires

Information from the National Library of Medicine

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): NCT00468637


Contacts
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

Locations
Germany
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         
Sponsors and Collaborators
University Hospital, Saarland
Pfizer
Investigators
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