Hypertrophic CardiomyopathyNCT03327623
Sleep Apnea and Hypertrophic Cardiomyopathy (HCM)
An observational study of Hypertrophic Cardiomyopathy, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators are trying to find out how common sleep apnea is in hypertrophic cardiomyopathy. The purpose of this study is to see if sleep apnea is common in hypertrophic cardiomyopathy and if its presence is associated with changes in the functioning of the body. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2017to 21 Jun 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and Subjects from The Mayo Clinic Hypertrophic Cardiomyopathy (HCM) Registry who reside in Minnesota.
Who may be able to join
- Adults with a diagnosis of HCM
- Able to consent
- Non-pregnant
- Healthy Controls free of hypertrophic cardiomyopathy and without a definitive family history of hypertrophic cardiomyopathy.
Who cannot join
- Decompensated Heart failure at time of enrollment (prior history of HF is not an exclusion criteria)
- Severe (known) Chronic obstructive pulmonary disease (COPD) (FEV1 between 30 and 50 percent of normal)
- Vulnerable study populations except for minorities (minorities may be targeted to achieve 25% minority recruitment required by the NIH)
- Pregnant women
- Children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prevalence and Incidence Study Investigating the Burden of Atrial and Ventricular Arrhythmias in Patients With Hypertrophic Cardiomyopathy and Sleep Apnea.
The investigators are trying to find out how common sleep apnea is in hypertrophic cardiomyopathy. The purpose of this study is to see if sleep apnea is common in hypertrophic cardiomyopathy and if its presence is associated with changes in the functioning of the body. The investigators want to determine if sleep apnea is associated with electrical disorders of the heart in patients with hypertrophic cardiomyopathy.
Read the detailed description
Participants will be healthy volunteers or subjects with the diagnosis of hypertrophic cardiomyopathy (HCM). All patients will a undergo a one time; medical history, physical examination, questionnaires, sleep observation in hospital, blood and urine samples, ultrasound scan of the heart, paced breathing test, ultrasound of brachial artery in the arm, MRI of the heart \& 48 hour ECG Holter monitoring. Comparison between the normal volunteers and subjects with HCM will be made.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- sleep apnea, arrhythmia
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Sleep Apnea Syndromes, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertrophic Cardiomyopathy (HCM) | Subjects with a diagnosis of Hypertrophic Cardiomyopathy | |
| Control | Subjects who are healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Obstructive Sleep Apnea (OSA).
Measured by the Apnea-hypopnea index (AHI). The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, sleep apnea is diagnosed if an AHI ≥5 events/hour.
Measured: Approximately 2 years.
Determine the severity of Sleep Apnea.
The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI < 5 per hour, Mild: AHI ≥ 5, but < 15 per hour, Moderate: AHI ≥ 15, but < 30 per hour, Severe: AHI ≥ 30 per hour.
Measured: Approximately 2 years.
Differences in Autonomic Regulation.
In persons with hypertrophic cardiomyopathy and sleep apnea vs. those without sleep apnea.
Measured: Approximately 2 years.
Prevalence of atrial arrhythmias.
Investigators will determine prevalence of atrial arrhythmias, based on prior ECG documented atrial arrhythmias at any timepoint prior to enrolment and up to 4 weeks after the study date. Participants will also have a 48h ECG (extended Holter) recorder attached to screen for atrial arrhythmias.
Measured: Approximately 2 years.
Incidence of atrial arrhythmias.
Measured: Approximately 5 years.
Frequency of ventricular arrhythmias.
Investigators will prospectively follow patients with hypertrophic cardiomyopathy to determine the frequency of ventricular arrhythmias in those with vs those without sleep apnea.
Measured: Approximately 5 years.
Secondary outcomes (2)
Identify novel biomarkers
Participants will be prospectively followed and blood collected to identify biomarkers of arrhythmia, heart failure and prognosis in persons with hypertrophic cardiomyopathy.
Measured: Approximately 5 years
Investigate the association of sleep apnea with atrial and ventricular fibrosis
Participants will undergo baseline MRI studies of the heart to determine the burden of fibrosis and its association with sleep apnea. Participants may be invited to complete a follow-up study to track changes in fibrosis.
Measured: Approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start13 Nov 2017
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
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
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327623
- Sponsor's protocol ID
- 17-003514
- Other IDs
- 1R01HL134885-01
- Status last verified
- Mar 2025
- First submitted
- 25 Oct 2017
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prevalence and Incidence Study Investigating the Burden of Atrial and Ventricular Arrhythmias in Patients With Hypertrophic Cardiomyopathy and Sleep Apnea.
- ClinicalTrials.gov ID
- NCT03327623
- Acronym / sponsor ID
- 17-003514
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- sleep apnea, arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 31 Oct 2017 (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 investigators are trying to find out how common sleep apnea is in hypertrophic cardiomyopathy. The purpose of this study is to see if sleep apnea is common in hypertrophic cardiomyopathy and if its presence is associated with changes in the functioning of the body. The investigators want to determine if sleep apnea is associated with electrical disorders of the heart in patients with hypertrophic cardiomyopathy.
Detailed description
Participants will be healthy volunteers or subjects with the diagnosis of hypertrophic cardiomyopathy (HCM). All patients will a undergo a one time; medical history, physical examination, questionnaires, sleep observation in hospital, blood and urine samples, ultrasound scan of the heart, paced breathing test, ultrasound of brachial artery in the arm, MRI of the heart \& 48 hour ECG Holter monitoring. Comparison between the normal volunteers and subjects with HCM will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic Cardiomyopathy (HCM) | – | –Subjects with a diagnosis of Hypertrophic Cardiomyopathy |
| Control | – | –Subjects who are healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and Subjects from The Mayo Clinic Hypertrophic Cardiomyopathy (HCM) Registry who reside in Minnesota.
Key inclusion criteria (4 listed)
- Adults with a diagnosis of HCM
- Able to consent
- Non-pregnant
- Healthy Controls free of hypertrophic cardiomyopathy and without a definitive family history of hypertrophic cardiomyopathy.
Key exclusion criteria (5 listed)
- Decompensated Heart failure at time of enrollment (prior history of HF is not an exclusion criteria)
- Severe (known) Chronic obstructive pulmonary disease (COPD) (FEV1 between 30 and 50 percent of normal)
- Vulnerable study populations except for minorities (minorities may be targeted to achieve 25% minority recruitment required by the NIH)
- Pregnant women
- Children
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
Prevalence of Obstructive Sleep Apnea (OSA).
Time frame: Approximately 2 years.
Measured by the Apnea-hypopnea index (AHI). The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, sleep apnea is diagnosed if an AHI ≥5 events/hour.
Determine the severity of Sleep Apnea.
Time frame: Approximately 2 years.
The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI < 5 per hour, Mild: AHI ≥ 5, but < 15 per hour, Moderate: AHI ≥ 15, but < 30 per hour, Severe: AHI ≥ 30 per hour.
Differences in Autonomic Regulation.
Time frame: Approximately 2 years.
In persons with hypertrophic cardiomyopathy and sleep apnea vs. those without sleep apnea.
Prevalence of atrial arrhythmias.
Time frame: Approximately 2 years.
Investigators will determine prevalence of atrial arrhythmias, based on prior ECG documented atrial arrhythmias at any timepoint prior to enrolment and up to 4 weeks after the study date. Participants will also have a 48h ECG (extended Holter) recorder attached to screen for atrial arrhythmias.
Incidence of atrial arrhythmias.
Time frame: Approximately 5 years.
Frequency of ventricular arrhythmias.
Time frame: Approximately 5 years.
Investigators will prospectively follow patients with hypertrophic cardiomyopathy to determine the frequency of ventricular arrhythmias in those with vs those without sleep apnea.
2 secondary outcomes
Identify novel biomarkers
Time frame: Approximately 5 years
Investigate the association of sleep apnea with atrial and ventricular fibrosis
Time frame: Approximately 7 years
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 26 Mar 2025.
- 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.
Virend Somers, 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 5 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 26 Mar 2025. 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?
Prevalence of Obstructive Sleep Apnea (OSA). (time frame: Approximately 2 years.). The study lists 6 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 26 Mar 2025.