Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

NCT00468637

Last updated date
Study Location
Gemeinschaftspraxis & Ambulante Tagesklinik
Merzig-Schwemlingen, Saarland, 66663, Germany
Contact
0049-6841-16-

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiovascular High-Risk, Chronic Heart Failure
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Impairment of hormonal status


- Refusal of written informed consent


- Inability to complete the questionnaires

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Cardiovascular High-Risk, Chronic Heart FailureAssociation of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
NCT00468637
  1. Merzig-Schwemlingen, Saarland
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
Official Title Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population primary care clinic, outpatient department, general practitioner
Condition
  • Cardiovascular High-Risk
  • Chronic Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 2, 2007)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2011
Primary Completion Date Not Provided
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
Sex/Gender
Sexes Eligible for Study:Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Italy,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00468637
Other Study ID Numbers 133/04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Magnus Baumhäkel, Department of Cardiology, University Hospital of the Saarland
Study Sponsor University Hospital, Saarland
Collaborators Pfizer
Investigators
Principal Investigator:Michael Böhm, MDDepartment of Cardiology, University Hospital of the Saarland
Principal Investigator:Magnus Baumhäkel, MDDepartment of Cardiology, University Hospital of the Saarland
PRS Account University Hospital, Saarland
Verification Date February 2009