Clinical trial NCT00468637: Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
Official title: Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular High-Risk
Chronic Heart Failure
Keywords: heart failure
cardiovascular high risk
erectile dysfunction
cardiovascular disease
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-05-03
Enrollment: 1200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, outpatient department, general practitioner

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Department of Cardiology, University Hospital of the Saarland
state: Saarland
city: Merzig-Schwemlingen
country: Germany
facility: Gemeinschaftspraxis & Ambulante Tagesklinik
state: Saarland
city: Brescia
country: Italy
facility: Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia
city: Wroclaw
country: Poland
facility: Department of Cardiology, 4th Military Clinical Hospital
Study officials:
affiliation: Department of Cardiology, University Hospital of the Saarland
name: Michael Böhm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, University Hospital of the Saarland
name: Magnus Baumhäkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.