Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe (AMORE-Eur)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Heart Failure; Cardiovascular High-Risk

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Michael Böhm, MD; Phone Number: 23000 0049-6841-16-; Email: michael.boehm@uniklinikum-saarland.de
• Study Contact Backup: Name: Magnus Baumhäkel, MD; Phone Number: 23000 0049-6841-16-; Email: magnus@baumhaekel.de

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Recruiting
      • Department of Cardiology, University Hospital of the Saarland
      • Contact: Magnus Baumhäkel, MD; Phone Number: 23000 0049-6841-16; Email: magnus@baumhaekel.de
      • Principal Investigator: Magnus Baumhäkel, MD
      • Sub-Investigator: Mario Kratz
    • Merzig-Schwemlingen, Saarland, Germany, 66663
      • Recruiting
      • Gemeinschaftspraxis & Ambulante Tagesklinik
      • Contact: Volker Rettig-Ewen, MD; Phone Number: 992902 0049-6861; Email: praxis@rettig-ewen.de
      • Principal Investigator: Volker Rettig-Ewen, MD
• Italy
  • Brescia, Italy
    • Recruiting
    • Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia
    • Contact: Marco Metra, MD
    • Principal Investigator: Marco Metra, MD
    • Contact: Alberto Saporetti, MD; Email: alberto@funkgogh.it
    • Sub-Investigator: Alberto Saporetti, MD
• Poland
  • Wroclaw, Poland
    • Recruiting
    • Department of Cardiology, 4th Military Clinical Hospital
    • Contact: Ewa A Jankowska, MD; Email: ewa@antro.pan.wroc.pl
    • Contact: Piotr Ponikowski, MD
    • Sub-Investigator: Ewa A Jankowska, MD
    • Principal Investigator: Piotr Ponikowski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, outpatient department, general practitioner

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University Hospital, Saarland
• Collaborators: Pfizer
• Investigators: Principal Investigator: Michael Böhm, MD, Department of Cardiology, University Hospital of the Saarland; Principal Investigator: Magnus Baumhäkel, MD, Department of Cardiology, University Hospital of the Saarland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: May 2, 2007
• First Submitted That Met QC Criteria: May 2, 2007
• First Posted (Estimate): May 3, 2007

Study Record Updates

• Last Update Posted (Estimate): February 16, 2009
• Last Update Submitted That Met QC Criteria: February 13, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: cardiovascular disease; erectile dysfunction; heart failure; cardiovascular high risk
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 133/04