Hypertrophic CardiomyopathyNCT04112290
A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to Dec 2027
- 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: Adult patients with hypertrophic cardiomyopathy who are participating in (or previously participated in) Mayo Clinic study 17-003514 and/or 16-009474
Who may be able to join
- Currently or previously enrolled in 17-003514 and 16-009474
- Adults age >18 years-old with a diagnosis of hypertrophic cardiomyopathy
- Both sexes
- Able to consent
Who cannot join
- Vulnerable study population
- Known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation)
- Pacemaker/ICD implantation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.
Read the detailed description
Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Atrial fibrillation, Ventricular tachycardia, Arrhythmia, Hypertrophic cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Atrial Fibrillation, Tachycardia, Ventricular, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation incidence in hypertrophic cardiomyopathy
Define the incidence ratio of newly diagnosed atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
Measured: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Atrial fibrillation recurrence in hypertrophic cardiomyopathy
Determine the frequency of recurrent atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
Measured: Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring.
Ventricular arrhythmia incidence in hypertrophic cardiomyopathy
Define the incidence ratio of newly diagnosed ventricular arrhythmias in hypertrophic cardiomyopathy, with and without sleep apnea
Measured: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start5 Nov 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jeffrey B. Geske, Mayo Clinic
- Investigators
- Jeffrey Geske, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112290
- Sponsor's protocol ID
- 17-011376
- Status last verified
- Feb 2026
- First submitted
- 28 Sep 2019
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04112290
- Acronym / sponsor ID
- 17-011376
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Atrial fibrillation, Ventricular tachycardia, Arrhythmia, Hypertrophic cardiomyopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2019 (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 research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.
Detailed description
Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with hypertrophic cardiomyopathy who are participating in (or previously participated in) Mayo Clinic study 17-003514 and/or 16-009474
Key inclusion criteria (4 listed)
- Currently or previously enrolled in 17-003514 and 16-009474
- Adults age >18 years-old with a diagnosis of hypertrophic cardiomyopathy
- Both sexes
- Able to consent
Key exclusion criteria (4 listed)
- Vulnerable study population
- Known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation)
- Pacemaker/ICD implantation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial fibrillation incidence in hypertrophic cardiomyopathy
Time frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Define the incidence ratio of newly diagnosed atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
Atrial fibrillation recurrence in hypertrophic cardiomyopathy
Time frame: Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring.
Determine the frequency of recurrent atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
Ventricular arrhythmia incidence in hypertrophic cardiomyopathy
Time frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Define the incidence ratio of newly diagnosed ventricular arrhythmias in hypertrophic cardiomyopathy, with and without sleep apnea
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 5 Feb 2026.
- 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.
Jeffrey Geske, MD principal investigator
Mayo Clinic
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, run by Mayo Clinic 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 4 inclusion and 4 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 5 Feb 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?
Atrial fibrillation incidence in hypertrophic cardiomyopathy (time frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.). The study lists 3 primary outcomes in all. 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 5 Feb 2026.