Perfusion Abnormalities in Hypertrophic Cardiomyopathy | NCT06599229

Studies
Perfusion Abnormalities in Hypertrophic Cardiomyopathy

NCT06599229

Sponsor

University of Virginia

Status

Active, not recruiting

Last Update Posted

Apr 16, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Hypertrophic Cardiomyopathy (HCM)

Interventions

myocardial contrast echo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2025Actual

Primary Completion Date

May 30, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Sep 13, 2024

First Submission Date that Met QC Criteria

Sep 13, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak hyperemic perfusion	Myocardial contrast echo-derived myocardial blood flow at peak hyperemia (produced by regadenoson)	3 months

Secondary Outcomes

Measure	Description	Time Frame
Resting myocardial perfusion	Resting myocardial perfusion by MCE	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22903	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified data on patient demographics, HCM type, medication dose, transthoracic echo data, MCE perfusion imaging data at rest and during regadenoson

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002312	Cardiomyopathy, Hypertrophic

Ancestor Terms

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular

Browse Leaves

Not provided

Browse Branches

Not provided