Coronary Artery DiseasePhase 3NCT00348101
Effects of Beta-Blocker Therapy and Phosphodiesterase Inhibition on Cardiac Neurohormonal Activation
A Phase 3 study testing Combined therapy with enoximone and esmolol in people with Coronary Artery Disease, run by Klinikum Ludwigshafen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Combined therapy with enoximone and esmolol
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for major vascular surgery
- can sign informed consent before surgery
- documented CAD or risk factors for CAD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine Klinikum Ludwigshafen
Ludwigshafen, 67063
About this study
Official title: The Influence of Continuous Perioperative Beta-Blocker Therapy in Combination With Phosphodiesterase Inhibition on Cardiac Neurohormonal Activation and Myocardial Ischaemia in High-Risk Vascular Surgery Patients
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.
Read the detailed description
Cardiac complications, such as, myocardial infarction, heart failure, and life-threatening dysrhythmias, are the leading cause of perioperative death among patients undergoing major vascular surgery.
The pathogenesis of perioperative ischaemic events is most certainly multifactorial and includes persistent activation of several neurohormonal pathways, such as the natriuretic peptide system.
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 especially in patients who had or were at high risk for coronary artery disease. Therefore, the administration of β-blockers to all patients at high risk for coronary events who are scheduled to undergo major noncardiac surgery is strongly supported by consensus recommendations and clinical guidelines. Despite the evidence of benefit, β-blockers remain underutilized in clinical practice because of concerns of potential adverse effects such as a reduced inotropic state, which might result in myocardial depression, acute congestive heart failure, and hypotension [13]. Therefore, additional treatment with a positive inotropic agent might be needed.
Phosphodiesterase inhibitors (PDEIs) offer a favourable pharmacological profile in this setting and retain their haemodynamic effects in the face of full β-blockade. Preliminary data suggest that the combination of PDEI and β-blocker therapy may be better tolerated and allows for expression of the known effects of β-blocker therapy and improved myocardial functioning without the adverse effects of either therapy alone.
We therefore 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 documented to have a high prevalence of coronary artery disease and limited coronary reserve. BNP is chosen because of its pivotal role as a sensitive correlate of myocardial dysfunction and its prognostic value for predicting the short- and long-term risk of cardiac death across the entire spectrum of acute coronary syndromes.
- Conditions
- Coronary Artery Disease
- Being tested
- Combined therapy with enoximone and esmolol
- Keywords
- Patients undergoing major vascular surgery having documented CAD or risk factors for CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined therapy with enoximone and esmololDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Ludwigshafen
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Suttner, M.D., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348101
- Sponsor's protocol ID
- ESPEKLILU05
- Status last verified
- Apr 2007
- First submitted
- 3 Jul 2006
- Last updated
- 30 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19336536
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Continuous Perioperative Beta-Blocker Therapy in Combination With Phosphodiesterase Inhibition on Cardiac Neurohormonal Activation and Myocardial Ischaemia in High-Risk Vascular Surgery Patients
- ClinicalTrials.gov ID
- NCT00348101
- Acronym / sponsor ID
- ESPEKLILU05
- Conditions
- Coronary Artery Disease
- Keywords
- Patients undergoing major vascular surgery having documented CAD or risk factors for CAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Klinikum LudwigshafenUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- May 2007 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiac complications, such as, myocardial infarction, heart failure, and life-threatening dysrhythmias, are the leading cause of perioperative death among patients undergoing major vascular surgery.
The pathogenesis of perioperative ischaemic events is most certainly multifactorial and includes persistent activation of several neurohormonal pathways, such as the natriuretic peptide system.
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 especially in patients who had or were at high risk for coronary artery disease. Therefore, the administration of β-blockers to all patients at high risk for coronary events who are scheduled to undergo major noncardiac surgery is strongly supported by consensus recommendations and clinical guidelines. Despite the evidence of benefit, β-blockers remain underutilized in clinical practice because of concerns of potential adverse effects such as a reduced inotropic state, which might result in myocardial depression, acute congestive heart failure, and hypotension [13]. Therefore, additional treatment with a positive inotropic agent might be needed.
Phosphodiesterase inhibitors (PDEIs) offer a favourable pharmacological profile in this setting and retain their haemodynamic effects in the face of full β-blockade. Preliminary data suggest that the combination of PDEI and β-blocker therapy may be better tolerated and allows for expression of the known effects of β-blocker therapy and improved myocardial functioning without the adverse effects of either therapy alone.
We therefore 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 documented to have a high prevalence of coronary artery disease and limited coronary reserve. BNP is chosen because of its pivotal role as a sensitive correlate of myocardial dysfunction and its prognostic value for predicting the short- and long-term risk of cardiac death across the entire spectrum of acute coronary syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for major vascular surgery
- can sign informed consent before surgery
- documented CAD or risk factors for CAD
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined therapy with enoximone and esmolol | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2007.
- Derived from this study: PubMed 19336536Suttner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Suttner, M.D. principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combined therapy with enoximone and esmolol in people with Coronary Artery Disease, run by Klinikum Ludwigshafen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We hypothesize that the combination of PDEI and β-blocker therapy. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00348101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2007.