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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Saarland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00468637
First received: May 2, 2007
Last updated: February 13, 2009
Last verified: February 2009
  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

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

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

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by University Hospital, Saarland:
heart failure
cardiovascular high risk
erectile dysfunction
cardiovascular disease

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014