Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

NCT ID: NCT00468637

Last Updated: 2009-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-09-30

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.

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.

Conditions

Cardiovascular High-Risk; Chronic Heart Failure

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University Hospital, Saarland

OTHER

Sponsor Role: lead

Responsible Party

Department of Cardiology, University Hospital of the Saarland

Principal Investigators

Michael Böhm, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, University Hospital of the Saarland

Magnus Baumhäkel, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, University Hospital of the Saarland

Locations

Department of Cardiology, University Hospital of the Saarland

Homburg, Saarland, Germany

Site Status: RECRUITING

Gemeinschaftspraxis & Ambulante Tagesklinik

Merzig-Schwemlingen, Saarland, Germany

Site Status: RECRUITING

Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia

Brescia, , Italy

Site Status: RECRUITING

Department of Cardiology, 4th Military Clinical Hospital

Wroclaw, , Poland

Site Status: RECRUITING

Countries

Germany; Italy; Poland

Central Contacts

Michael Böhm, MD

Role: CONTACT

michael.boehm@uniklinikum-saarland.de

0049-6841-16- ext. 23000

Magnus Baumhäkel, MD

Role: CONTACT

magnus@baumhaekel.de

0049-6841-16- ext. 23000

Facility Contacts

Magnus Baumhäkel, MD

Role: primary

magnus@baumhaekel.de

0049-6841-16 ext. 23000

Volker Rettig-Ewen, MD

Role: primary

praxis@rettig-ewen.de

0049-6861 ext. 992902

Alberto Saporetti, MD

Role: primary

alberto@funkgogh.it

Marco Metra, MD

Role: backup

Ewa A Jankowska, MD

Role: primary

ewa@antro.pan.wroc.pl

Piotr Ponikowski, MD

Role: backup

References

Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.

Reference Type: BACKGROUND

PMID: 10637462 (View on PubMed)

Braun M, Wassmer G, Klotz T, Reifenrath B, Mathers M, Engelmann U. Epidemiology of erectile dysfunction: results of the 'Cologne Male Survey'. Int J Impot Res. 2000 Dec;12(6):305-11. doi: 10.1038/sj.ijir.3900622.

Reference Type: BACKGROUND

PMID: 11416833 (View on PubMed)

Petrone L, Mannucci E, Corona G, Bartolini M, Forti G, Giommi R, Maggi M. Structured interview on erectile dysfunction (SIEDY): a new, multidimensional instrument for quantification of pathogenetic issues on erectile dysfunction. Int J Impot Res. 2003 Jun;15(3):210-20. doi: 10.1038/sj.ijir.3901006.

Reference Type: BACKGROUND

PMID: 12904808 (View on PubMed)

Other Identifiers

133/04

Identifier Type: -

Identifier Source: org_study_id