Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiom… (NCT03953989) | Clinical Trial Compass
CompletedPhase 2
Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy
Italy26 participantsStarted 2016-10
Plain-language summary
To demonstrate the efficacy of ranolazine in improving coronary microvascular and diastolic dysfunction in patients affected by HCM evaluating changes in maximum (i.e. during dipyridamole-induced coronary vasodilatation) myocardial blood flow (MBF) measured by PET at baseline and after 4 months of treatment with ranolazine in patients with non obstructive HCM.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female gender (females of childbearing potential must be using highly effective contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner);
* Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test;
* Patients which fulfill conventional echocardiographic criteria for the diagnosis of HCM: maximum LV wall thickness ≥ 15 mm;
* Patients aged \> 18 years and \< 80 years;
* Sinus rhythm accepted isolated Supraventricular and Ventricular Premature Beats (VPB);
* Absence of severe resting LV outflow tract obstruction (peak gradient ≤ 50 mmHg);
* Written informed consent prior to enrolment into the study;
Exclusion Criteria:
* Females of childbearing potential not using highly effective contraceptive precautions;
* Presence of known coronary artery disease (CAD);
* Presence of Chronic Obstructive Airways Disease;
* Asthma;
* Other causes of microvascular dysfunction including long-standing history of arterial hypertension, diabetes, uncontrolled dyslipidemia;
* Body mass index \>32 kg/m2; \< 17 kg/m2
* Overt LV systolic dysfunction with end-stage progression (LV-EF \<50%);
* Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone);
* Patients treated with sotalol, dronedarone, …
What they're measuring
1
Myocardial Blood Flow during hyperemia ml/min/g
Timeframe: At baseline and after 4 months of treatment