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Clinical Trials/NCT00468637
NCT00468637UnknownNot Applicable

Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

University Hospital, Saarland4 sites in 3 countries1,200 target enrollmentStarted: May 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,200
Locations
4

Study Overview

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)

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
University Hospital, Saarland
Sponsor Class
Other

Study Sites (4)

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