A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

January 17, 2024 updated by: Jeffrey B. Geske, Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey Geske, M.D.
        • Sub-Investigator:
          • Virend Somers, M.D., Ph.D.
        • Sub-Investigator:
          • Choudhary Anwar Chahal, Ph.D.
        • Sub-Investigator:
          • Konstantinos Siontis, M.D.
        • Sub-Investigator:
          • Shahid Karim, M.B., Ch.B.
        • Sub-Investigator:
          • Shreyas Venkataraman, M.B.B.S.
        • Sub-Investigator:
          • Meghna Mansukhani, M.D.
        • Sub-Investigator:
          • Peter Noseworthy, M.D.
        • Sub-Investigator:
          • Jan Bukartyk, M.S.
        • Sub-Investigator:
          • Sean Caples, D.O., M.S.
        • Sub-Investigator:
          • Yong-Mei Cha, M.D.
        • Sub-Investigator:
          • Thomas Foley, M.D.
        • Sub-Investigator:
          • Paul Friedman, M.D.
        • Sub-Investigator:
          • Bernard Gersh, M.B., Ch.B.
        • Sub-Investigator:
          • Amar Killu, M.B.B.S.
        • Sub-Investigator:
          • Grace Lin, M.D.
        • Sub-Investigator:
          • Rick Nishimura, M.D.
        • Sub-Investigator:
          • Thomas Olson, Ph.D., M.S.
        • Sub-Investigator:
          • Steve Ommen, M.D.
        • Sub-Investigator:
          • Phillip Schulte, Ph.D.
        • Sub-Investigator:
          • Erik St Louis, M.D.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with hypertrophic cardiomyopathy who are participating in (or previously participated in) Mayo Clinic study 17-003514 and/or 16-009474

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Vulnerable study population
  • Known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation)
  • Pacemaker/ICD implantation
  • Pregnancy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
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
Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring.
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
Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Medtronic

Investigators

  • Principal Investigator: Jeffrey Geske, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

November 5, 2019

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 28, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-011376

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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