Hypertrophic CardiomyopathyNCT04905173
Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy
A study testing Squat-to-stand maneuver, Amyl nitrite inhalation and Valsalva in people with Hypertrophic Cardiomyopathy and Hypertrophic Obstructive Cardiomyopathy, run by Mayo Clinic.
Trial summary
The purpose of this study is to assess the effectiveness of squat-to-stand maneuver in eliciting left ventricular outflow gradients in patients with Hypertrophic Cardiomyopathy (HCM) compared to Valsalva, amyl nitrite inhalation, and exercise stress echocardiogram (ESE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy, Cardiomyopathy, Hypertrophic
- What is being tested?
- Squat-to-stand maneuver, Amyl nitrite inhalation and Valsalva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to May 2022
- Phase
- Interventional
- 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
- Adults ≥ 18 y/o referred for an outpatient echocardiogram.
- Clinical diagnosis of Hypertrophic Cardiomyopathy (HCM).
- Both amyl nitrite inhalation and squat-to-stand maneuver performed during echocardiogram.
Who cannot join
- Patients < 18 at the time of echocardiogram.
- Studies without documented provocative maneuvers.
- Patients with resting obstruction (MIG > 50 mmHg).
- Patients unable to undergo the squat-to-stand as protocolled based because of physical limitations.
- Patient with contraindications to amyl nitrite administration.
About this study
The purpose of this study is to assess the effectiveness of squat-to-stand maneuver in eliciting left ventricular outflow gradients in patients with Hypertrophic Cardiomyopathy (HCM) compared to Valsalva, amyl nitrite inhalation, and exercise stress echocardiogram (ESE).
Read the detailed description
Left ventricular hypertrophy and abnormal ventricular configuration result in dynamic left ventricular outflow obstruction in ~75% of HCM patients, which is associated with increased cardiac morbidity and mortality. However, the dynamic nature of the gradient can make obstruction difficult to identify. Provocative maneuvers such as Valsalva maneuver, administration of amyl nitrite, and ESE are currently used to assess for obstruction.
A shortage of amyl nitrite beginning in December 2018 spurred a search for alternative provocative maneuvers. Beginning in February 2019, the Mayo Clinic echocardiography laboratory began utilizing a squat-to-stand maneuver as an alternative to amyl nitrite inhalation. Anecdotally, the squat-to-stand maneuver, which decreases both preload and afterload, has been successful in provoking latent left ventricular outflow obstruction. A retrospective study (Peng et al, in progress) studying 119 patients who performed the squat-to-stand maneuver between February and September 2019 demonstrated squat-to-stand to be a more robust provocative maneuver than the Valsalva maneuver for identifying severe dynamic left ventricular obstruction with Doppler echocardiography. Squat-to-stand elicited latent obstruction in a greater proportion of the study participants and higher average gradients. It also demonstrated the potential to alter clinical management - six patients had severe obstruction only with squat-to-stand (otherwise would not have been diagnosed) and subsequently underwent septal reduction surgery.
The recent return of amyl nitrite to the echocardiography laboratory creates an opportunity for direct comparison with squat-to-stand, particularly regarding cost savings and diagnostic performance. The primary purpose of this study is to evaluate the efficacy and degree of provocation of left ventricular outflow gradients by the squat-to-stand maneuver compared to amyl nitrite inhalation in patients with HCM undergoing echocardiography. Squat-to-stand will also be compared with other provocation methods, including Valsalva maneuver, which should be performed on every patient going on to squat-to-stand, and ESE when available. Validating this novel provocative maneuver can broaden the toolbox of techniques used to elicit left ventricular outflow gradients and improve clinical evaluation and management of symptomatic HCM patients.
- Conditions
- Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy, Cardiomyopathy, Hypertrophic
- Being tested
- Squat-to-stand maneuver, Amyl nitrite inhalation, Valsalva
- Keywords
- squat to stand maneuver, amyl nitrite, echocardiography, valsalva, exercise stress echocardiography, left ventricular outflow tract obstruction, maximal instantaneous gradient, hypertrophic cardiomyopathy, latent obstruction, dynamic obstruction, squat-to-stand
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Ventricular Outflow Obstruction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squat-to-stand maneuverOther
Subjects will squat for 5 seconds and then stand. The squat-to-stand exercise will be done up to 10 times, and then immediately undergo echocardiographic imaging.
Amyl nitrite inhalationDrug
Subjects will inhale amyl nitrite prior to undergoing echocardiographic imaging. This is administered according to current laboratory protocol and is part of standard of care. This is an FDA-regulated drug that will be used as a control and will not be studied experimentally.
ValsalvaOther
Subjects will undergo echocardiographic imaging while performing the Valsalva maneuver. This is according to current laboratory protocol and is part of standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Hypertrophic Cardiomyopathy | Experimental | Subjects with a documented diagnosis of hypertrophic cardiomyopathy (HCM) will have an echocardiogram at rest followed by an echocardiogram with Valsalva maneuver as part of regular care. If these tests show no severe obstruction, subjects will continue with both squat-to-stand and amyl nitrite. Receives: Other: Squat-to-stand maneuver; Drug: Amyl nitrite inhalation; Other: Valsalva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe provokable obstruction
Percentage of patients with provokable obstruction (rest gradient < 30 mmHg AND gradient w/ maneuver ≥ 30 mmHg) by provocation technique
Measured: Baseline
Secondary outcomes (2)
Maximal instantaneous gradient
Maximal instantaneous gradient (MIG) by provocation technique measured in mm Hg
Measured: Baseline
Completion of squat-to-stand maneuver
Percentage of patients unable to complete a squat-to-stand maneuver
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study startNov 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: The decision was made by study team to pursue this as a quality project instead.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey B. Geske, Mayo Clinic
- Investigators
- Jeffrey Geske, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905173
- Sponsor's protocol ID
- 21-003194
- Status last verified
- Dec 2021
- First submitted
- 23 May 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04905173
- Acronym / sponsor ID
- 21-003194
- Conditions
- Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy, Cardiomyopathy, Hypertrophic
- Keywords
- squat to stand maneuver, amyl nitrite, echocardiography, valsalva, exercise stress echocardiography, left ventricular outflow tract obstruction, maximal instantaneous gradient, hypertrophic cardiomyopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The decision was made by study team to pursue this as a quality project instead.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 27 May 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.
The purpose of this study is to assess the effectiveness of squat-to-stand maneuver in eliciting left ventricular outflow gradients in patients with Hypertrophic Cardiomyopathy (HCM) compared to Valsalva, amyl nitrite inhalation, and exercise stress echocardiogram (ESE).
Detailed description
Left ventricular hypertrophy and abnormal ventricular configuration result in dynamic left ventricular outflow obstruction in ~75% of HCM patients, which is associated with increased cardiac morbidity and mortality. However, the dynamic nature of the gradient can make obstruction difficult to identify. Provocative maneuvers such as Valsalva maneuver, administration of amyl nitrite, and ESE are currently used to assess for obstruction.
A shortage of amyl nitrite beginning in December 2018 spurred a search for alternative provocative maneuvers. Beginning in February 2019, the Mayo Clinic echocardiography laboratory began utilizing a squat-to-stand maneuver as an alternative to amyl nitrite inhalation. Anecdotally, the squat-to-stand maneuver, which decreases both preload and afterload, has been successful in provoking latent left ventricular outflow obstruction. A retrospective study (Peng et al, in progress) studying 119 patients who performed the squat-to-stand maneuver between February and September 2019 demonstrated squat-to-stand to be a more robust provocative maneuver than the Valsalva maneuver for identifying severe dynamic left ventricular obstruction with Doppler echocardiography. Squat-to-stand elicited latent obstruction in a greater proportion of the study participants and higher average gradients. It also demonstrated the potential to alter clinical management - six patients had severe obstruction only with squat-to-stand (otherwise would not have been diagnosed) and subsequently underwent septal reduction surgery.
The recent return of amyl nitrite to the echocardiography laboratory creates an opportunity for direct comparison with squat-to-stand, particularly regarding cost savings and diagnostic performance. The primary purpose of this study is to evaluate the efficacy and degree of provocation of left ventricular outflow gradients by the squat-to-stand maneuver compared to amyl nitrite inhalation in patients with HCM undergoing echocardiography. Squat-to-stand will also be compared with other provocation methods, including Valsalva maneuver, which should be performed on every patient going on to squat-to-stand, and ESE when available. Validating this novel provocative maneuver can broaden the toolbox of techniques used to elicit left ventricular outflow gradients and improve clinical evaluation and management of symptomatic HCM patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic Cardiomyopathy | Experimental | Other: Squat-to-stand maneuver, Drug: Amyl nitrite inhalation, Other: ValsalvaSubjects with a documented diagnosis of hypertrophic cardiomyopathy (HCM) will have an echocardiogram at rest followed by an echocardiogram with Valsalva maneuver as part of regular care. If these tests show no severe obstruction, subjects will continue with both squat-to-stand and amyl nitrite. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 18 y/o referred for an outpatient echocardiogram.
- Clinical diagnosis of Hypertrophic Cardiomyopathy (HCM).
- Both amyl nitrite inhalation and squat-to-stand maneuver performed during echocardiogram.
Key exclusion criteria (5 listed)
- Patients < 18 at the time of echocardiogram.
- Studies without documented provocative maneuvers.
- Patients with resting obstruction (MIG > 50 mmHg).
- Patients unable to undergo the squat-to-stand as protocolled based because of physical limitations.
- Patient with contraindications to amyl nitrite administration.
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 |
|---|---|---|
| Squat-to-stand maneuverSubjects will squat for 5 seconds and then stand. The squat-to-stand exercise will be done up to 10 times, and then immediately undergo echocardiographic imaging. | Other | Hypertrophic Cardiomyopathy |
| Amyl nitrite inhalationSubjects will inhale amyl nitrite prior to undergoing echocardiographic imaging. This is administered according to current laboratory protocol and is part of standard of care. This is an FDA-regulated drug that will be used as a control and will not be studied experimentally. | Drug | Hypertrophic Cardiomyopathy |
| ValsalvaSubjects will undergo echocardiographic imaging while performing the Valsalva maneuver. This is according to current laboratory protocol and is part of standard of care. | Other | Hypertrophic Cardiomyopathy |
Primary outcome
Severe provokable obstruction
Time frame: Baseline
Percentage of patients with provokable obstruction (rest gradient < 30 mmHg AND gradient w/ maneuver ≥ 30 mmHg) by provocation technique
2 secondary outcomes
Maximal instantaneous gradient
Time frame: Baseline
Completion of squat-to-stand maneuver
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Jeffrey Geske, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Squat-to-stand maneuver, Amyl nitrite inhalation and Valsalva in people with Hypertrophic Cardiomyopathy and Hypertrophic Obstructive Cardiomyopathy, run by Mayo Clinic.
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 5 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: withdrawn, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Severe provokable obstruction (time frame: Baseline). 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 11 Jan 2022.