NCT07054073

Brief Summary

This study aims to learn what might predict heart problems (like sudden death from a fast heart rhythm or heart failure) in people with a genetic condition called hypertrophic cardiomyopathy (HCM). HCM causes the heart muscle to become thick, which can make the heart stiff and harder to work properly. It can also affect the heart's electrical system. This study is looking to enroll patients that were previously part of a research project called "HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy." The results of that study are still being reviewed, but they might show that people who had a substance called Gadolinium (MRI contrast or dye) collected in their heart muscle may have a higher risk for heart problems, including sudden cardiac death. This is called "late gadolinium enhancement" (LGE). This study is aiming to do follow-up imaging on those patients to better understand how LGE affects people with HCM.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Mar 2026

Geographic Reach
2 countries

8 active sites

Status
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 Progress17%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

June 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

June 27, 2025

Last Update Submit

March 17, 2026

Conditions

Hypertrophic Cardiomyopathy (HCM)

Outcome Measures

Primary Outcomes (1)

  • Change in % LGE mass

    To assess the change in LGE extent from baseline over a minimum of 7 years of follow-up extent in HCM patients who would have been candidates for clinical trials of aficamten.

    From baseline over a minimum of 7 years

Study Arms (2)

Obstructive HCM

Other: None - observational study

Non-obstructive HCM

Other: None - observational study

Interventions

None - observational studyOTHER

None - observational study

Non-obstructive HCMObstructive HCM

Eligibility Criteria

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

Participants from the HCMR original cohort who also meet this study's eligibility criteria.

You may qualify if:

  • Patients in the original HCMR cohort with:
  • Obstructive HCM
  • Males and females between 18 and 65 years of age
  • BMI \< 35 kg/m2
  • LVOT-G at entry as follows:
  • Resting gradient ≥50 mmHg OR Resting gradient ≥30 mmHg and \<50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
  • NYHA Class II or III or
  • Non-obstructive HCM
  • Same criteria as above except resting LVOT-G is \<30mmHg and post-Valsalva gradient \<50mm Hg
  • BMI \<40kg/m2
  • Elevated NT-proBNP \> 300 pg/mL at the time of enrollment
  • LVEF ≥55%

You may not qualify if:

  • Paroxysmal atrial fibrillation or flutter documented prior to entry.
  • History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to entry.
  • Pregnancy due to potential risk of gadolinium to the fetus
  • Patients with a pacemaker that are pacer-dependent as they cannot undergo MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Northwestern

Evanston, Illinois, 60208, United States

NOT YET RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Tufts Medical Center

Medford, Massachusetts, 02155, United States

NOT YET RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

NOT YET RECRUITING

London Chest Hospital

London, E2 9JX, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Christopher Kramer, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

  • Stefan Neubauer, MD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gina Duda

CONTACT

434-924-9553gms4x@uvahealth.org

Thuy Le

CONTACT

DZV5SQ@uvahealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
University of Virginia Health System

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

March 30, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

US(6)GB(2)