Clinical trial: A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy (NCT01559714)

Eligibility criteria:
Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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;

          -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Entailment