Hypertrophic CardiomyopathyBE STRONG HCMNCT01559714
A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by Heartcenter, University Medical Center St. Radboud at 1 site in Netherlands.
Trial summary
Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical HCM). Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and pre-clinical HCM patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to 1 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of clinical or pre-clinical HCM patients that are registered in the HCM database of the HCM outpatient clinic of University Medical Center St. Radboud. This database will be screened for eligible patients according to the in- and exclusion criteria described below.
Who may be able to join
- Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC guidelines or individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy (pre-clinical HCM patients);
- Age ≥ 18 years;
- Able to comply with the protocol;
- Written informed consent.
Who cannot join
- Known significant epicardial coronary artery disease;
- Patients with LVH in the clinical setting of other disorders that explain the myocardial hypertrophy (amyloidosis, MELAS, Anderson-Fabry, WPW etc.);
- Heart failure NYHA class III-IV;
- Patients with known hemodynamic instability or syncope during exercise due to left ventricular outflow gradient or occurrence of ventricular arrhythmia;
- History of PTSMA (percutaneous transluminal septal myocardial ablation) or Morrow myectomy;
- Patients not able to complete a bicycle test;
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- Any contraindication to MR imaging (MR imaging is not obligatory for assessment of the primary objective, therefore relative exclusion criterion);
- Recent (within 30 days) admittance to the hospital for any cardiac reason (myocardial infarction, heart failure, cardiac arrhythmia, etc.);
- Severe renal insufficiency (eGFR < 30 ml/min);
- Any other condition which, in the opinion of the investigator, may pose a significant hazard to the subject if he or she participates in the present study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Heartcenter, University Medical Center St. Radboud
Nijmegen, Gelderland, 6525 GA
About this study
Official title: BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study
Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical HCM).
Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and pre-clinical HCM patients.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Troponin, Exercise, MRI
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Motor Activity
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 |
|---|---|---|
| Clinical HCM patients | Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC and ACCF/AHA guidelines | |
| Pre-clinical HCM patients | Individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay
Measured: Baseline, 6 and 24 hours after exercise
Secondary outcomes (1)
Correlation between troponin levels and phenotypic characteristics assessed with MRI (LV volumes, mass and ejection fraction, presence of LGE and/or elevated signal on T2-weighted imaging)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startApr 2012
- Primary completion1 May 2019
- Study completion1 May 2019
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.
- 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartcenter, University Medical Center St. Radboud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.H.F. Gommans, MD, Heartcenter, University Medical Center St. Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559714
- Sponsor's protocol ID
- NL37776.091.11
- Acronym
- BE STRONG HCM
- Status last verified
- Jul 2020
- First submitted
- 19 Mar 2012
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study
- ClinicalTrials.gov ID
- NCT01559714
- Acronym / sponsor ID
- BE STRONG HCM / NL37776.091.11
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Troponin, Exercise, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Heartcenter, University Medical Center St. RadboudUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 21 Mar 2012 (estimated)
- 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.
Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical HCM).
Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and pre-clinical HCM patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical HCM patients | – | –Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC and ACCF/AHA guidelines |
| Pre-clinical HCM patients | – | –Individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of clinical or pre-clinical HCM patients that are registered in the HCM database of the HCM outpatient clinic of University Medical Center St. Radboud. This database will be screened for eligible patients according to the in- and exclusion criteria described below.
Key inclusion criteria (4 listed)
- Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC guidelines or individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy (pre-clinical HCM patients);
- Age ≥ 18 years;
- Able to comply with the protocol;
- Written informed consent.
Key exclusion criteria (10 listed)
- Known significant epicardial coronary artery disease;
- Patients with LVH in the clinical setting of other disorders that explain the myocardial hypertrophy (amyloidosis, MELAS, Anderson-Fabry, WPW etc.);
- Heart failure NYHA class III-IV;
- Patients with known hemodynamic instability or syncope during exercise due to left ventricular outflow gradient or occurrence of ventricular arrhythmia;
- History of PTSMA (percutaneous transluminal septal myocardial ablation) or Morrow myectomy;
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
Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay
Time frame: Baseline, 6 and 24 hours after exercise
1 secondary outcome
Correlation between troponin levels and phenotypic characteristics assessed with MRI (LV volumes, mass and ejection fraction, presence of LGE and/or elevated signal on T2-weighted imaging)
Time frame: Baseline
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 7 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heartcenter, University Medical Center St. Radboud at 1 site in Netherlands.
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 10 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 7 Jul 2020. 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 Netherlands. 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?
Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay (time frame: Baseline, 6 and 24 hours after exercise). 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 7 Jul 2020.