Hypertrophic Cardiomyopathy (HCM)NCT06599229
Perfusion Abnormalities in Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy (HCM), run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- What is being tested?
- myocardial contrast echo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with HCM who are being started on cardiac myosin inhibitor therapy.
Who may be able to join
- Diagnosis of hypertrophic cardiomyopathy
- Subject being initiated on clinically-indicated cardiac myosin inhibitor therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: 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.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- myocardial contrast echo
- Keywords
- hypertrophic cardiomyopathy, myocardial contrast echocardiography, microvascular perfusion
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myocardial contrast echoDiagnostic test
Vasodilator stress myocardial contrast echocardiography will be performed at baseline and within 4 months of reaching target dose of a cardiac myosin inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: myocardial contrast echo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak hyperemic perfusion
Myocardial contrast echo-derived myocardial blood flow at peak hyperemia (produced by regadenoson)
Measured: 3 months
Secondary outcomes (1)
Resting myocardial perfusion
Resting myocardial perfusion by MCE
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Jan 2025
- Primary completion30 May 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Lindner, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599229
- Sponsor's protocol ID
- 301910
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data on patient demographics, HCM type, medication dose, transthoracic echo data, MCE perfusion imaging data at rest and during regadenoson
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion Abnormalities in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06599229
- Acronym / sponsor ID
- 301910
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- hypertrophic cardiomyopathy, myocardial contrast echocardiography, microvascular perfusion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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 investigate whether myocardial microvascular perfusion in patients with hypertrophic cardiomyopathy improved after initiation of cardiac myosin inhibitor therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HCM initiated on cardiac myosin inhibitor therapy | – | Diagnostic Test: myocardial contrast echoPatients with HCM who are being initiated on cardiac myosin inhibitor therapy for clinically indicated reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HCM who are being started on cardiac myosin inhibitor therapy.
Key inclusion criteria (2 listed)
- Diagnosis of hypertrophic cardiomyopathy
- Subject being initiated on clinically-indicated cardiac myosin inhibitor therapy
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation
- Allergy to ultrasound enhancing agent (lipid-stabilized) or regadenoson
- Serious AE to regadenoson
- Hypotension
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 |
|---|---|---|
| myocardial contrast echoVasodilator stress myocardial contrast echocardiography will be performed at baseline and within 4 months of reaching target dose of a cardiac myosin inhibitor. | Diagnostic test | Patients with HCM initiated on cardiac myosin inhibitor therapy |
Primary outcome
Peak hyperemic perfusion
Time frame: 3 months
Myocardial contrast echo-derived myocardial blood flow at peak hyperemia (produced by regadenoson)
1 secondary outcome
Resting myocardial perfusion
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data on patient demographics, HCM type, medication dose, transthoracic echo data, MCE perfusion imaging data at rest and during regadenoson
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy (HCM), run by University of Virginia at 1 site in United States.
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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Peak hyperemic perfusion (time frame: 3 months). 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 16 Apr 2026.