Hypertrophic CardiomyopathyNCT02806479
Hypertrophic Cardiomyopathy Pilot Study
An observational study of Hypertrophic Cardiomyopathy and Coronary Artery Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Coronary Artery Disease
- What is being tested?
- Observational: Arrhythmogenic Substrate
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Case - Control study of hypertrophic cardiomyopathy patients at high risk for ventricular arrhythmias in comparison to three Controls groups
Who may be able to join
- Diagnosed HCM
- Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest
- Maximal left ventricular wall thickness of > 30mm
- Extensive fibrosis on cardiac MRI (>15% of total myocardial volume)
- >7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD
Who cannot join
- age < 18 years
- Pregnancy
- Atrial Fibrillation
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk
This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate
- Being tested
- Observational: Arrhythmogenic Substrate
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational: Arrhythmogenic SubstrateOther
| Study group | Role | What they receive |
|---|---|---|
| Case: Hypertrophic cardiomyopathy | HCM patients at high risk for ventricular arrhythmia Receives: Other: Observational: Arrhythmogenic Substrate | |
| Control I: Healthy | Healthy Controls | |
| Control II: Post-MI with arrhythmogenic substrate | Ischemic cardiomyopathy patients with documented history of ventricular tachyarrhythmia and left ventricular hypertrophy Receives: Other: Observational: Arrhythmogenic Substrate | |
| Control III: VT/VF-free ischemic cardiomyopathy | Ischemic cardiomyopathy patients without ventricular arrhythmia, as proven by non-inducibility and history of freedom from ventricular tachyarrhythmia during at least one ICD generator life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasively reconstructed epicardial activation map
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larisa Tereshchenko, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806479
- Sponsor's protocol ID
- 15049
- Status last verified
- Sep 2020
- First submitted
- 16 Jun 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Perez-Alday EA, Haq KT, German DM, Hamilton C, Johnson K, Phan F, Rogovoy NM, Yang K, Wirth A, Thomas JA, Dalouk K, Fuss C, Ferencik M, Heitner S, Tereshchenko LG. Mechanisms of Arrhythmogenicity in Hypertrophic Cardiomyopathy: Insight From Non-invasive Electrocardiographic Imaging. Front Physiol. 2020 Apr 24;11:344. doi: 10.3389/fphys.2020.00344. eCollection 2020.
PubMed 32390862
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk
- ClinicalTrials.gov ID
- NCT02806479
- Acronym / sponsor ID
- 15049
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Case: Hypertrophic cardiomyopathy | – | Other: Observational: Arrhythmogenic SubstrateHCM patients at high risk for ventricular arrhythmia |
| Control I: Healthy | – | –Healthy Controls |
| Control II: Post-MI with arrhythmogenic substrate | – | Other: Observational: Arrhythmogenic SubstrateIschemic cardiomyopathy patients with documented history of ventricular tachyarrhythmia and left ventricular hypertrophy |
| Control III: VT/VF-free ischemic cardiomyopathy | – | –Ischemic cardiomyopathy patients without ventricular arrhythmia, as proven by non-inducibility and history of freedom from ventricular tachyarrhythmia during at least one ICD generator life |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Case - Control study of hypertrophic cardiomyopathy patients at high risk for ventricular arrhythmias in comparison to three Controls groups
Key inclusion criteria (5 listed)
- Diagnosed HCM
- Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest
- Maximal left ventricular wall thickness of > 30mm
- Extensive fibrosis on cardiac MRI (>15% of total myocardial volume)
- >7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD
Key exclusion criteria (3 listed)
- age < 18 years
- Pregnancy
- Atrial Fibrillation
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 |
|---|---|---|
| Observational: Arrhythmogenic Substrate | Other | Case: Hypertrophic cardiomyopathy, Control II: Post-MI with arrhythmogenic substrate |
Primary outcome
Non-invasively reconstructed epicardial activation map
Time frame: within one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Results publication: PubMed 32390862Perez-Alday EA, Haq KT, German DM, Hamilton C, Johnson K, Phan F, Rogovoy NM, Yang K, Wirth A, Thomas JA, Dalouk K, Fuss C, Ferencik M, Heitner S, Tereshchenko LG. Mechanisms of Arrhythmogenicity in Hypertrophic Cardiomyopathy: Insight From Non-invasive Electrocardiographic Imaging. Front Physiol. 2020 Apr 24;11:344. doi: 10.3389/fphys.2020.00344. eCollection 2020.
- Individual participant dataSharing planned: No
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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 and Coronary Artery Disease, run by Oregon Health and Science University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 16 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Non-invasively reconstructed epicardial activation map (time frame: within one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02806479, which also lists 1 linked publication.
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 Sep 2020.