Aortic Valve StenosisDALLASNCT05015829
Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis
An observational study of Aortic Valve Stenosis and Valvular Stenosis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
When aortic valve-area is <1.0cm2 and transvalvular mean-gradient is >40mmHg, the diagnosis of severe aortic stenosis (AS) is straightforward. However, some patients present with an apparently reduced valve-area, despite transvalvular-gradient <40mmHg; Low-flow, low-gradient aortic stenosis (LFLG AS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Valvular Stenosis, Valvular Heart Disease
- What is being tested?
- Dobutamine Stress Echocardiography
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 31 Aug 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with LFLG AS followed at the Department of Cardiology, Odense University Hospital will be offered participation in the study.
Who may be able to join
- Low-flow (SVi<35 ml/m2) low-gradient (mean gradient <40 mmHg) AS with estimated AVA<1.0 cm2 referred to the Department of Cardiology, Odense University Hospital.
- Age > 18 years.
- Signed informed consent.
Who cannot join
- Other moderate-severe valvular heart disease.
- Unwilling to participate in the study.
- Poor echocardiographic window.
- Inability to follow-up due to temporary citizenship Registration Number (CPR-Number) or emigration within the study period.
- Pregnant women.
- Patients with severe chronic renal failure (eGFR<40 ml/min) will not undergo cardiac MRi or CT angiography.
- Known contrast allergy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Fune, 5000
Nils Mogensen, MD, 61283671 ext. +45, nils.sofus.borg.mogensen@rsyd.dk
About this study
When aortic valve-area is <1.0cm2 and transvalvular mean-gradient is >40mmHg, the diagnosis of severe aortic stenosis (AS) is straightforward. However, some patients present with an apparently reduced valve-area, despite transvalvular-gradient <40mmHg; Low-flow, low-gradient aortic stenosis (LFLG AS). When a patient with LFLG AS also presents with LVEF <50%, guidelines recommends performing a Low-Dose Dobutamine-echocardiography (LDDE) to confirm true-severe AS. However, nearly 30% of patients with LFLG AS do not show an adequate respond to Dobutamine. More commonly, patients present with the combination of LFLG AS, despite LVEF≥50%. In this group of patients the use of LDDE remains undisclosed.
The purpose of this study is to examine the safety and diagnostic usefulness of LDDE in patients with LFLG AS with LVEF≥50%. Furthermore we will examine factors associated with inadequate response to LDDE.
Read more
150 symptomatic and/or asymptomatic patients with LFLG and LVEF≥50% and a control group with LVEF<50% will be enrolled at the Department of Cardiology, OUH. Patients will undergo clinical evaluation including LDDE, blood analyses, CT-scan and cardiac Mri.
Only a limited number of studies examine the possible use of LDDE in patients with LFLG AS and LVEF≥50% and no study has been performed documenting the safety and feasibility.
- Being tested
- Dobutamine Stress Echocardiography
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine Stress EchocardiographyDiagnostic test
Change in echocardiographic 2D and doppler measurements during infusion with Dobutamine 5 µg/kg/min till max dosage of 20 µg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Classical low-flow low-gradient aortic stenosis | LVEF<50% SVi < 35.0 mL/m2 Aortic mean gradient < 40 mmHg AVA < 1.0 cm2. Receives: Diagnostic Test: Dobutamine Stress Echocardiography | |
| Paradoxical low-flow low-gradient aortic stenosis | LVEF>50% SVi < 35.0 mL/m2 Aortic mean gradient < 40 mmHg AVA < 1.0 cm2. Receives: Diagnostic Test: Dobutamine Stress Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects during Dobutamine infusion
- The occurrence of angina pectoris, severely high systolic blood pressure >200 mmHg or ventricular premature beats Lown Grade >3 or supra-ventricular arrhythmias or tachycardia assessed by ECG.
- Occurrence of signs of echocardiographic subvalvular obstruction; (systolic anterior motion of the mitral leaflet (SAM), high velocities (>2 m/sec) in the LV outflow tract and late peaking systolic jet).
Measured: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
- Gender (male/female).
Measured: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
- Aortic valve calcification assessed by cardiac CT (AU).
Measured: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
- Myocardial fibrosis assessed by MRi (%).
Measured: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
- Baseline myocardial systolic and diastolic function estimated by echocardiography (Global Longitudinal Strain (%), Strain Ratesystolic (SRs), deceleration time of mitral E-wave (ms) and end-systolic wall-stress corrected LVEF (dynes).
Measured: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
- The ongoing use of beta-blockers (%, dosis).
Measured: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
- Association with outcomes (rate of AVR, hospitalization for cardiac failure, death).
Measured: Dobutamine infusion, up to 30 minutes
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Rate of AVR
Measured: 1 day til 3 years
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Hospitalization for cardiac failure
Measured: 1 day til 3 years
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
All-cause mortality
Measured: 1 day til 3 years
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Cardiovascular mortality
Measured: 1 day til 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Sep 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark
- Responsible party
- Principal investigator, Nils Sofus Borg Mogensen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015829
- Sponsor's protocol ID
- S-20190058
- Other IDs
- 19/34844
- Acronym
- DALLAS
- Status last verified
- Aug 2021
- First submitted
- 15 Jul 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis
- ClinicalTrials.gov ID
- NCT05015829
- Acronym / sponsor ID
- DALLAS / S-20190058
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 20 Aug 2021 (actual)
- 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.
When aortic valve-area is <1.0cm2 and transvalvular mean-gradient is >40mmHg, the diagnosis of severe aortic stenosis (AS) is straightforward. However, some patients present with an apparently reduced valve-area, despite transvalvular-gradient <40mmHg; Low-flow, low-gradient aortic stenosis (LFLG AS). When a patient with LFLG AS also presents with LVEF <50%, guidelines recommends performing a Low-Dose Dobutamine-echocardiography (LDDE) to confirm true-severe AS. However, nearly 30% of patients with LFLG AS do not show an adequate respond to Dobutamine. More commonly, patients present with the combination of LFLG AS, despite LVEF≥50%. In this group of patients the use of LDDE remains undisclosed.
The purpose of this study is to examine the safety and diagnostic usefulness of LDDE in patients with LFLG AS with LVEF≥50%. Furthermore we will examine factors associated with inadequate response to LDDE.
150 symptomatic and/or asymptomatic patients with LFLG and LVEF≥50% and a control group with LVEF<50% will be enrolled at the Department of Cardiology, OUH. Patients will undergo clinical evaluation including LDDE, blood analyses, CT-scan and cardiac Mri.
Only a limited number of studies examine the possible use of LDDE in patients with LFLG AS and LVEF≥50% and no study has been performed documenting the safety and feasibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical low-flow low-gradient aortic stenosis | – | Diagnostic Test: Dobutamine Stress EchocardiographyLVEF<50% SVi < 35.0 mL/m2 Aortic mean gradient < 40 mmHg AVA < 1.0 cm2. |
| Paradoxical low-flow low-gradient aortic stenosis | – | Diagnostic Test: Dobutamine Stress EchocardiographyLVEF>50% SVi < 35.0 mL/m2 Aortic mean gradient < 40 mmHg AVA < 1.0 cm2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with LFLG AS followed at the Department of Cardiology, Odense University Hospital will be offered participation in the study.
Key inclusion criteria (3 listed)
- Low-flow (SVi<35 ml/m2) low-gradient (mean gradient <40 mmHg) AS with estimated AVA<1.0 cm2 referred to the Department of Cardiology, Odense University Hospital.
- Age > 18 years.
- Signed informed consent.
Key exclusion criteria (7 listed)
- Other moderate-severe valvular heart disease.
- Unwilling to participate in the study.
- Poor echocardiographic window.
- Inability to follow-up due to temporary citizenship Registration Number (CPR-Number) or emigration within the study period.
- Pregnant women.
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 |
|---|---|---|
| Dobutamine Stress EchocardiographyChange in echocardiographic 2D and doppler measurements during infusion with Dobutamine 5 µg/kg/min till max dosage of 20 µg/kg/min. | Diagnostic test | Classical low-flow low-gradient aortic stenosis, Paradoxical low-flow low-gradient aortic stenosis |
Primary outcome
Adverse effects during Dobutamine infusion
Time frame: Dobutamine infusion, up to 30 minutes
1. The occurrence of angina pectoris, severely high systolic blood pressure >200 mmHg or ventricular premature beats Lown Grade >3 or supra-ventricular arrhythmias or tachycardia assessed by ECG. 2. Occurrence of signs of echocardiographic subvalvular obstruction; (systolic anterior motion of the mitral leaflet (SAM), high velocities (>2 m/sec) in the LV outflow tract and late peaking systolic jet).
Factors associated with flow-reserve
Time frame: Dobutamine infusion, up to 30 minutes
a) Gender (male/female).
Factors associated with flow-reserve
Time frame: Dobutamine infusion, up to 30 minutes
b) Aortic valve calcification assessed by cardiac CT (AU).
Factors associated with flow-reserve
Time frame: Dobutamine infusion, up to 30 minutes
c) Myocardial fibrosis assessed by MRi (%).
Factors associated with flow-reserve
Time frame: Dobutamine infusion, up to 30 minutes
d) Baseline myocardial systolic and diastolic function estimated by echocardiography (Global Longitudinal Strain (%), Strain Ratesystolic (SRs), deceleration time of mitral E-wave (ms) and end-systolic wall-stress corrected LVEF (dynes).
Factors associated with flow-reserve
Time frame: Dobutamine infusion, up to 30 minutes
e) The ongoing use of beta-blockers (%, dosis).
Factors associated with flow-reserve
Time frame: Dobutamine infusion, up to 30 minutes
f) Association with outcomes (rate of AVR, hospitalization for cardiac failure, death).
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Time frame: 1 day til 3 years
Rate of AVR
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Time frame: 1 day til 3 years
Hospitalization for cardiac failure
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Time frame: 1 day til 3 years
All-cause mortality
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Time frame: 1 day til 3 years
Cardiovascular mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Valvular Stenosis, run by Odense University Hospital 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 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: status not confirmed, as of the sponsor's last update on 20 Aug 2021. 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.
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?
Contact Nils Mogensen, MD (61286371 ext. +45, nils.sofus.borg.mogensen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effects during Dobutamine infusion (time frame: Dobutamine infusion, up to 30 minutes). The study lists 11 primary outcomes in all. 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 20 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.