Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy

NCT04905173 | Withdrawn

• 1 other identifier: 21-003194
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

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; latent obstruction; dynamic obstruction; squat-to-stand

Outcome Measures

Primary Outcomes (1)

• Severe provokable obstruction

  Percentage of patients with provokable obstruction (rest gradient \< 30 mmHg AND gradient w/ maneuver ≥ 30 mmHg) by provocation technique

  Baseline

Secondary Outcomes (2)

• Maximal instantaneous gradient

  Baseline

• Completion of squat-to-stand maneuver

  Baseline

Study Arms (1)

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.

Other: Squat-to-stand maneuver; Drug: Amyl nitrite inhalation; Other: Valsalva

Interventions

Squat-to-stand maneuver OTHER

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.

Hypertrophic Cardiomyopathy

Amyl nitrite inhalation DRUG

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.

Hypertrophic Cardiomyopathy

Valsalva OTHER

Subjects will undergo echocardiographic imaging while performing the Valsalva maneuver. This is according to current laboratory protocol and is part of standard of care.

Hypertrophic Cardiomyopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Ventricular Outflow Obstruction, Left

Interventions

Valsalva Maneuver

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Respiratory Physiological Phenomena

Study Officials

• Jeffrey Geske, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: May 27, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12