Clinical trial: The Role of Heart Stiff and Weak Atrium on Exercise Capacity in Patients With Hypertrophic Cardiomyopathy (NCT00074880)

Eligibility criteria:
INCLUSION CRITERIA - HCM Patients:

        HCM defined as maximal LV wall thickness by echocardiography greater than 13mm in the
        absence of other causes of LVH or greater than 15mm asymmetrical LV wall thickness if there
        is a history of mild hypertension (defined as systolic less than 160mmHg and diastolic less
        than 100mHg) controlled for greater than 6 months

        Non-obstructive HCM

        Age greater than or equal to 21 years.

        Patients with LV obstruction treated by LV myotomy and myectomy or percutaneous septal
        alcohol ablation that meet inclusion criteria are eligible for this study.

        EXCLUSION CRITERIA - HCM Patients:

        LV outflow obstruction noted during Doppler echocardiography at rest or with Valsalva
        maneuver defined as instantaneous peak gradient greater than 30 mmHg

        Hemodynamically significant valvular disorders, history of significant coronary obstruction
        (greater than 50% in any single artery), angina symptoms, myocardial ischemia on an imaging
        stress test or evidence of prior myocardial infarction. Patients older than 40 years of age
        with effort induced anginal symptoms typical of coronary insufficiency and a coronary
        distribution of myocardial ischemia on an imaging stress test will be considered for the
        study if coronary angiography rules out significant obstructive coronary disease.

        Chronic atrial fibrillation

        Cardiac pacemaker or other metallic implant unsafe for MRI

        Uncontrolled hypertension

        Dependence on a beta blocker that cannot be withdrawn

        Dependence on a calcium blocker that cannot be withdrawn

        Current use of digoxin

        History of digitalis intolerance

        Renal failure

        Diabetes mellitus

        Pregnancy or lactation

        Failure to indicate effective method of birth control measures if female patient is of
        childbearing age.

        Inability to exercise or disease states likely to result in impaired exercise capacity
        (such as pulmonary, hematological and musculoskeletal disorders)

        Echocardiographic images of insufficient quality, even after administration of contrast
        agent, for volumetric analysis.

        Inability to provide informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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