Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
NCT00468637
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Adult Trials: 18+ Years
- 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
- Impairment of hormonal status
- Refusal of written informed consent
- Inability to complete the questionnaires
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- Merzig-Schwemlingen, Saarland
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe | ||||||
| Official Title | Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe | ||||||
| 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
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. | ||||||
| Study Type | Observational | ||||||
| Study Design | Time Perspective: Prospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | primary care clinic, outpatient department, general practitioner | ||||||
| Condition |
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| Intervention | Not Provided | ||||||
| Study Groups/Cohorts | Not Provided | ||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Unknown status | ||||||
| Estimated Enrollment | 1200 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | September 2011 | ||||||
| Primary Completion Date | Not Provided | ||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Germany, Italy, Poland | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT00468637 | ||||||
| Other Study ID Numbers | 133/04 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Dr. Magnus Baumhäkel, Department of Cardiology, University Hospital of the Saarland | ||||||
| Study Sponsor | University Hospital, Saarland | ||||||
| Collaborators | Pfizer | ||||||
| Investigators |
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| PRS Account | University Hospital, Saarland | ||||||
| Verification Date | February 2009 | ||||||