Clinical trial: REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease in HCM (NCT04219826)

Eligibility criteria:
Inclusion Criteria

          -  Males and females between 18 and 85 years of age at screening.

          -  Body weight is ≥45 kg at screening.

          -  Diagnosed with oHCM per the following criteria:

               -  Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence
                  of other cardiac disease.

               -  Has minimal wall thickness ≥15 mm (minimal wall thickness ≥13 mm is acceptable
                  with a positive family history of HCM or with a known disease-causing gene
                  mutation).

          -  Adequate acoustic windows for echocardiography.

          -  Has LVOT-G during screening as follows:

               -  Resting gradient ≥50 mmHg OR

               -  Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg

          -  LVEF ≥60% at screening.

          -  New York Heart Association (NYHA) Class II or III at screening.

          -  Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on
             stable doses for >4 weeks prior to randomization and anticipate remaining on the same
             medication regimen during the study.

        Exclusion Criteria

          -  Aortic stenosis or fixed subaortic obstruction.

          -  Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM
             (eg, Noonan syndrome, Fabry disease, amyloidosis).

          -  History of LV systolic dysfunction (LVEF <45%) at any time during their clinical
             course.

          -  Documented history of current obstructive coronary artery disease (>70% stenosis in
             one or more epicardial coronary arteries) or documented history of myocardial
             infarction.

          -  Has been treated with septal reduction therapy (surgical myectomy or percutaneous
             alcohol septal ablation) or has plans for either treatment during the study period.

          -  Has been treated with disopyramide or antiarrhythmic drugs that have negative
             inotropic activity within 4 weeks prior to screening.

          -  Paroxysmal atrial fibrillation or flutter documented during the screening period.

          -  Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg,
             direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months
             prior to screening. (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 screening.

          -  Has received prior treatment with CK-3773274 or is currently receiving mavacamten.
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.
Subject must be at most 85 Years

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