Perfusion Abnormalities in Hypertrophic Cardiomyopathy

NCT06599229 | Active Not Recruiting

• 1 other identifier: 301910
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether myocardial microvascular perfusion in patients with hypertrophic cardiomyopathy improved after initiation of cardiac myosin inhibitor therapy.

Conditions

Hypertrophic Cardiomyopathy (HCM)

Keywords

hypertrophic cardiomyopathy; myocardial contrast echocardiography; microvascular perfusion

Outcome Measures

Primary Outcomes (1)

• Peak hyperemic perfusion

  Myocardial contrast echo-derived myocardial blood flow at peak hyperemia (produced by regadenoson)

  3 months

Secondary Outcomes (1)

• Resting myocardial perfusion

  3 months

Study Arms (1)

Patients with HCM initiated on cardiac myosin inhibitor therapy

Patients with HCM who are being initiated on cardiac myosin inhibitor therapy for clinically indicated reasons.

Diagnostic Test: myocardial contrast echo

Interventions

myocardial contrast echo DIAGNOSTIC_TEST

Vasodilator stress myocardial contrast echocardiography will be performed at baseline and within 4 months of reaching target dose of a cardiac myosin inhibitor.

Patients with HCM initiated on cardiac myosin inhibitor therapy

Eligibility Criteria

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

Study Population

Patients with HCM who are being started on cardiac myosin inhibitor therapy.

You may qualify if:

• Diagnosis of hypertrophic cardiomyopathy
• Subject being initiated on clinically-indicated cardiac myosin inhibitor therapy

You may not qualify if:

• Pregnancy
• Lactation
• Allergy to ultrasound enhancing agent (lipid-stabilized) or regadenoson
• Serious AE to regadenoson
• Hypotension
• Serious bradycardia not addressed by pacemaker
• Moderate or greater reactive airways disease

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: January 2, 2025
• Primary Completion: May 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: December 2024; End-date not determined but no sooner than December 2028
• Access Criteria: Any investigators requesting access to data after publication of results.

Locations

US (1)