Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe - Full Text View

Sponsors and Collaborators:	University Hospital, Saarland Pfizer
Information provided by:	University Hospital, Saarland
ClinicalTrials.gov Identifier:	NCT00468637

Purpose

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.

Condition
Cardiovascular High-Risk Chronic Heart Failure

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

Further study details as provided by University Hospital, Saarland:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1200
Study Start Date:	May 2007
Estimated Study Completion Date:	September 2011

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

Evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients.
Evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men.
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.

IIEF-5 - (International Index of Erectile Function)
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic, outpatient department, general practitioner

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468637

Contacts

Contact: Michael Böhm, MD	0049-6841-16- ext 23000	michael.boehm@uniklinikum-saarland.de
Contact: Magnus Baumhäkel, MD	0049-6841-16- ext 23000	magnus@baumhaekel.de

Locations

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

Sponsors and Collaborators

University Hospital, Saarland

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

More Information

Publications:

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.

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.

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.

Responsible Party:	Department of Cardiology, University Hospital of the Saarland ( Dr. Magnus Baumhäkel )
Study ID Numbers:	133/04
Study First Received:	May 2, 2007
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00468637 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital, Saarland:

heart failure
cardiovascular high risk
erectile dysfunction
cardiovascular disease

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Erectile Dysfunction

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009