Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

Chronic Heart Failure Clinical Trial

— AMORE-Eur  

Official title:

Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00468637
• Other study ID #: 133/04
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2007
• Last updated: February 13, 2009
• Start date: May 2007
• Est. completion date: September 2011

Study information

• Verified date: February 2009
• Source: University Hospital, Saarland
• Contact: Michael Böhm, MD
• Phone: 0049-6841-16-
• Email: michael.boehm[@]uniklinikum-saarland.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular High-Risk
• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Germany	Department of Cardiology, University Hospital of the Saarland	Homburg	Saarland
Germany	Gemeinschaftspraxis & Ambulante Tagesklinik	Merzig-Schwemlingen	Saarland
Italy	Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia	Brescia
Poland	Department of Cardiology, 4th Military Clinical Hospital	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Saarland	Pfizer

Countries where clinical trial is conducted

Germany,  Italy,  Poland, 

References & Publications (3)

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. — View 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. — View Citation

Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña 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. — View Citation