NCT04112290

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Nov 2019Dec 2027

First Submitted

Initial submission to the registry

September 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

8.1 years

First QC Date

September 28, 2019

Last Update Submit

February 3, 2026

Conditions

Hypertrophic Cardiomyopathy

Keywords

Atrial fibrillationVentricular tachycardiaArrhythmiaHypertrophic cardiomyopathy

Outcome Measures

Primary Outcomes (3)

  • Atrial fibrillation incidence in hypertrophic cardiomyopathy

    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

    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

    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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicAtrial FibrillationTachycardia, VentricularArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Study Officials

  • Jeffrey Geske, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2019

First Posted

October 2, 2019

Study Start

November 5, 2019

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)