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HCMR Re-Imaging Study

Sponsor: Christopher Kramer

NCT ID: NCT07054073

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
None - observational study (other)
How long the study runs
Study runs about 16 months (dates as stated)
About the drug or intervention
None - observational study — other: None - observational study
Patient visit burden
Not specified by the sponsor

In plain English

This study is inviting back people who took part in an earlier study called the HCMR cohort and who have hypertrophic cardiomyopathy (HCM), a condition where the heart muscle becomes thicker than normal. The study is looking at both people whose blood flow out of the heart is partly blocked (obstructive HCM) and people whose is not (non-obstructive HCM).

Who can take part

  • You took part in the original HCMR study
  • You are aged 18 to 65
  • You have obstructive HCM: a measurement of blood flow out of the heart (called LVOT-G) of 50 mmHg or more at rest, or 30 to 50 mmHg at rest rising to 50 mmHg or more after a breathing manoeuvre called Valsalva
  • You are in NYHA Class II or III (a scale doctors use to describe how much heart symptoms limit your daily activity)
  • OR you have non-obstructive HCM: blood flow measurement below 30 mmHg at rest and below 50 mmHg after Valsalva
  • For obstructive HCM your BMI (body mass index) must be under 35; for non-obstructive HCM it must be under 40
  • For non-obstructive HCM: a blood test marker called NT-proBNP above 300 pg/mL at enrolment, and heart pumping strength (LVEF, left ventricular ejection fraction) of 55% or more

Who may not be able to

  • Episodes of atrial fibrillation or atrial flutter (irregular heart rhythms) recorded before joining, or treated with procedures or rhythm-control medicines within 6 months of joining (this does not apply if treated with blood thinners and heart rate well controlled for over 6 months)
  • Fainting or a dangerous fast heart rhythm brought on by exercise within 6 months of joining
  • Pregnancy, because the MRI scan dye (gadolinium) could harm the baby
  • Having a pacemaker and depending on it, because MRI scans are not possible

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years to 65 Years
Who
All
Number of participants
314
Started
2026-03-30
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for hypertrophic cardiomyopathy (hcm)
  • • Clinical study - 314 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with hypertrophic cardiomyopathy (hcm)

Where?

  • • Birmingham - University Hospitals Birmingham NHS Foundation Trust
  • • London - London Chest Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Hypertrophic Cardiomyopathy (HCM)

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

What the study is looking for

  • ✓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:

Who cannot take part

  • ✗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
See the full criteria
Inclusion Criteria: Patients in the original HCMR cohort with: 1. 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 2. 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% Exclusion Criteria: * Paroxysmal atrial fibrillation or flutter documented prior to entry. * Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to entry. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for \>6 months.) * 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

Where Is This Study? (2 UK sites)

University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2GW, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

London Chest Hospital

London E2 9JX, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

How to Get in Touch

Gina Duda

Sponsor contact

CONTACT

434-924-9553 gms4x@uvahealth.org

Thuy Le

Sponsor contact

CONTACT

DZV5SQ@uvahealth.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-03