NCT00348101

Brief Summary

Previous clinical investigations have demonstrated the utility of β-adrenergic blockade in reducing perioperative ischaemic events, ultimately translating into a decrease in cardiac morbidity and mortality. However, β-blocker therapy remains underutilized in clinical practice because of concerns of potential adverse effects such as a reduced inotropic state, which might result in acute congestive heart failure or hypotension. Therefore, additional treatment with a positive inotropic agent might be needed. Phosphodiesterase inhibitors (PDEIs) offer a favourable pharmacological profile in this setting and stimulate cardiac function in the absence of the β-adrenergic receptor. We hypothesize that the combination of PDEI and β-blocker therapy would decrease perioperative plasma concentrations of brain natriuretic peptide (BNP) in patients requiring major vascular surgery. BNP is chosen as our primary outcome variable because of its importance as a sensitive correlate of myocardial dysfunction and its prognostic value for predicting the risk of cardiac death across the entire spectrum of acute coronary syndromes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 30, 2007

Status Verified

April 1, 2007

First QC Date

July 3, 2006

Last Update Submit

May 29, 2007

Conditions

Coronary Artery Disease

Keywords

Patients undergoing major vascular surgery having documented CAD or risk factors for CAD

Outcome Measures

Primary Outcomes (3)

  • We hypothesize that the combination of PDEI and β-blocker therapy

  • would decrease perioperative plasma concentrations of brain natriuretic peptide

  • BNP) in patients requiring major vascular surgery.

Interventions

Combined therapy with enoximone and esmololDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for major vascular surgery
  • can sign informed consent before surgery
  • documented CAD or risk factors for CAD

You may not qualify if:

  • Preoperative treatment with beta-adrenergic agonists or glucocorticoids,
  • electrocardiographic (ECG) abnormalities like nonsinus rhythm, second- or third degree heart block, or left bundle branch block,
  • cardiac pacemaker dependency,
  • symptomatic mitral or aortic valvular disease,
  • a history of asthma, bronchospasm, or severe chronic obstructive pulmonary disease necessitating bronchodilator therapy,
  • severe liver dysfunction
  • known allergies against the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Related Publications (1)

  • Suttner S, Boldt J, Mengistu A, Lang K, Mayer J. Influence of continuous perioperative beta-blockade in combination with phosphodiesterase inhibition on haemodynamics and myocardial ischaemia in high-risk vascular surgery patients. Br J Anaesth. 2009 May;102(5):597-607. doi: 10.1093/bja/aep062. Epub 2009 Mar 31.

    PMID: 19336536DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Psychotherapy, MultipleEnoximoneesmolol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Stefan Suttner, M.D.

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Study Completion

May 1, 2007

Last Updated

May 30, 2007

Record last verified: 2007-04

Locations

DE(1)