Heart FailurePhase 4NCT01375335
The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
A Phase 4 study testing Dobutamine in people with Heart Failure, run by University of Aarhus at 1 site in Denmark.
Trial summary
The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. This study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Dobutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Aug 2013
- Phase
- Phase 4
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-90 years
- Left ventricular posterior wall =/>12mm
- Ejection fraction > 45%
- Sinus rhythm
- Eligible for aortic valve replacement
Who cannot join
- Need for concomitant cardiac bypass operation.
- Moderate or severe insufficiency of the mitral valve
- Active endocarditis
- Insufficient ultrasound window
- Using B-blockers
- Liver insufficiency
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- Patients treated with COMT-inhibitors
- Allergy towards dobutamine
- Pregnancy
- Women of fertile age who do not use relevant anti-conception
- Lacking participant consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesia & Intensive Care, Århus University Hospital
Aarhus, 8200
About this study
Official title: The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis
The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. This study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.
- Conditions
- Heart Failure
- Being tested
- Dobutamine
- Keywords
- Postoperative, Dobutamine, Inotropes, Stunning, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized
| Study group | Role | What they receive |
|---|---|---|
| Dobutamine | Experimental | Not described Receives: Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Change in cardiac output (l/min) from initiation of study drug or placebo until 90 minutes of infusion.
Measured: From 0 to 90 minutes after drug initiation
Secondary outcomes (5)
Mean pulmonary artery pressure
Changes in pulmonary artery pressure (mmHg) from start of study drug or placebo infusion until 90 minutes after the start.
Measured: From 0 to 90 minutes after drug initiation.
Echocardiography
Echocardiographic measures of systolic and diastolic heart function.
Measured: From 0 minutes to 90 minutes after drug initiation
Changes in mixed venous saturation
Changes in mixed venous saturation (in per cent) from baseline until the end of dobutrex or placebo infusion.
Measured: From 0 minutes to 90 minutes after drug initiation
norepinephrine requirement
The amount of norepinephrinem(mg) required to maintain adequate systemic blood pressure during the infusion period of dobutrex and placebo
Measured: From 0 minutes to 90 minutes after drug initiation
Central venous pressure
Changes in CVP from baseline until 90 minutes of study drug or placebo infusion.
Measured: From 0 minutes to 90 minutes after drug initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2013
Why it stopped: Insufficient patient eligible for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Sloth, Professor, Study chair, Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375335
- Sponsor's protocol ID
- 1818
- Status last verified
- Aug 2013
- First submitted
- 14 Jun 2011
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT01375335
- Acronym / sponsor ID
- 1818
- Conditions
- Heart Failure
- Keywords
- Postoperative, Dobutamine, Inotropes, Stunning, Heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Insufficient patient eligible for recruitment
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2013 (actual)
- First posted
- 17 Jun 2011 (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.
The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. This study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dobutamine | Experimental | Drug: Dobutamine |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-90 years
- Left ventricular posterior wall =/>12mm
- Ejection fraction > 45%
- Sinus rhythm
- Eligible for aortic valve replacement
Key exclusion criteria (11 listed)
- Need for concomitant cardiac bypass operation.
- Moderate or severe insufficiency of the mitral valve
- Active endocarditis
- Insufficient ultrasound window
- Using B-blockers
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 |
|---|---|---|
| Dobutamine90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized | Drug | Dobutamine |
Primary outcome
Cardiac output
Time frame: From 0 to 90 minutes after drug initiation
Change in cardiac output (l/min) from initiation of study drug or placebo until 90 minutes of infusion.
5 secondary outcomes
Mean pulmonary artery pressure
Time frame: From 0 to 90 minutes after drug initiation.
Echocardiography
Time frame: From 0 minutes to 90 minutes after drug initiation
Changes in mixed venous saturation
Time frame: From 0 minutes to 90 minutes after drug initiation
norepinephrine requirement
Time frame: From 0 minutes to 90 minutes after drug initiation
Central venous pressure
Time frame: From 0 minutes to 90 minutes after drug initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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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.
Erik Sloth, Professor study chair
Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dobutamine in people with Heart Failure, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 11 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: paused, as of the sponsor's last update on 7 Aug 2013. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Cardiac output (time frame: From 0 to 90 minutes after drug initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2013.