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Status unknownNCT00468637AMORE-EurUpdated Feb 16, 2009

Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

An observational study in Cardiovascular High-Risk and Chronic Heart Failure, sponsored by University Hospital, Saarland. Status unknown at 4 sites in 3 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-16.

Sponsored by University Hospital, Saarland · Observational

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
1,200
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular High-Risk
  • Chronic Heart Failure

Keywords

  • heart failure
  • cardiovascular high risk
  • erectile dysfunction
  • cardiovascular disease
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Hospital, Saarland is the lead sponsor of 43 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

primary care clinic, outpatient department, general practitioner

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Impairment of hormonal status
  • Refusal of written informed consent
  • Inability to complete the questionnaires
05

Study design

Time perspective
Prospective
Enrollment
1,200 participants (estimated)
06

Study locations

4 of 4 sites recruiting
  • Department of Cardiology, University Hospital of the Saarland
    Homburg, Saarland 66421, Germany
    • Magnus Baumhäkel, MD · Contact · magnus@baumhaekel.de · 0049-6841-16
    • Magnus Baumhäkel, MD · Principal investigator
    • Mario Kratz · Sub investigator
    Recruiting
  • Gemeinschaftspraxis & Ambulante Tagesklinik
    Merzig-Schwemlingen, Saarland 66663, Germany
    • Volker Rettig-Ewen, MD · Contact · praxis@rettig-ewen.de · 0049-6861
    • Volker Rettig-Ewen, MD · Principal investigator
    Recruiting
  • Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia
    Brescia, Italy
    • Alberto Saporetti, MD · Contact · alberto@funkgogh.it
    • Marco Metra, MD · Contact
    • Alberto Saporetti, MD · Sub investigator
    • Marco Metra, MD · Principal investigator
    Recruiting
  • Department of Cardiology, 4th Military Clinical Hospital
    Wroclaw, Poland
    • Ewa A Jankowska, MD · Contact · ewa@antro.pan.wroc.pl
    • Piotr Ponikowski, MD · Contact
    • Ewa A Jankowska, MD · Sub investigator
    • Piotr Ponikowski, MD · Principal investigator
    Recruiting
07

References and documents

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. doi: 10.1038/sj.ijir.3900472. PubMed 10637462 ↗
  • 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. PubMed 11416833 ↗
  • 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. PubMed 12904808 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2007 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2007
First posted
May 3, 2007
Start
May 2007
CompletionEst.
Sep 2011
Last update
Feb 16, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00468637
Lead sponsor
University Hospital, Saarland
Collaborators
Pfizer
First posted
May 3, 2007
Start date
May 2007
Completion
Sep 2011 (estimated)
Last update
Feb 16, 2009

Study contacts

Michael Böhm, MD
Contact
michael.boehm@uniklinikum-saarland.de
0049-6841-16- ext. 23000
Magnus Baumhäkel, MD
Contact
magnus@baumhaekel.de
0049-6841-16- ext. 23000
Michael Böhm, MD
principal investigator · Department of Cardiology, University Hospital of the Saarland
Magnus Baumhäkel, MD
principal investigator · Department of Cardiology, University Hospital of the Saarland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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