Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

• Conditions: Cardiovascular High-Risk; Chronic Heart Failure

• Registration Number: NCT00468637
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-02
• Study First Submitted QC: 2007-05-02
• Study First Posted: 2007-05-03
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-13
• Last Update Posted: 2009-02-16
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Gemeinschaftspraxis & Ambulante Tagesklinik; 🇩🇪 Merzig-Schwemlingen, Saarland, Germany

Department of Cardiology, University Hospital of the Saarland; 🇩🇪 Homburg, Saarland, Germany

Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia; 🇮🇹 Brescia, Italy

Department of Cardiology, 4th Military Clinical Hospital; 🇵🇱 Wroclaw, Poland