- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06599229
Perfusion Abnormalities in Hypertrophic Cardiomyopathy
April 13, 2026 updated by: Jonathan Lindner, MD, University of Virginia
Myocardial Perfusion Abnormalities in Hypertrophic Cardiomyopathy
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- University of Virginia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with HCM who are being started on cardiac myosin inhibitor therapy.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Vasodilator stress myocardial contrast echocardiography will be performed at baseline and within 4 months of reaching target dose of a cardiac myosin inhibitor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak hyperemic perfusion
Time Frame: 3 months
|
Myocardial contrast echo-derived myocardial blood flow at peak hyperemia (produced by regadenoson)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting myocardial perfusion
Time Frame: 3 months
|
Resting myocardial perfusion by MCE
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2025
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
September 13, 2024
First Submitted That Met QC Criteria
September 13, 2024
First Posted (Actual)
September 19, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 13, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 301910
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data on patient demographics, HCM type, medication dose, transthoracic echo data, MCE perfusion imaging data at rest and during regadenoson
IPD Sharing Time Frame
December 2024; End-date not determined but no sooner than December 2028
IPD Sharing Access Criteria
Any investigators requesting access to data after publication of results.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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