Hypertrophic cardiomyopathy MedDRA version: 20.0 Level: PT Classification code 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: LLT Classification code 10020204 Term: HOCM Hypertrophic obstructive cardiomyopathy System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0 Level: LLT Classification code 10020203 Term: HOCM System Organ Class: 10010331 - Congenital,
Conditions
Interventions
Trade Name: RANEXA - 750 MG - COMPRESSA A RILASCIO PROLUNGATO- USO ORALE - BLISTER (PVC/PVDC/ALLUMINIO) 60 COMPRESSE
Product Name: Ranolazina Ranexa
Product Code: [C01EB18]
Pharmaceutical Form: Prolo
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female gender. 2. Patients who fulfil conventional echocardiographic criteria for the diagnosis of HCM: maximum LV wall thickness = 15 mm; 3. Patients aged > 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. severe resting LV outflow tract obstruction (peak gradient > 50 mmHg) 2. Females of childbearing potential not using highly effective contraception; 3. Presence of known coronary artery disease (CAD); 4. Presence of Chronic Obstructive Airways Disease; 5. Asthma; 6. Other causes of microvascular dysfunction including long-standing history of arterial hypertension, diabetes, uncontrolled dyslipidemia; 7. Body mass index >32 kg/m2; 2.5 mg/dL or BUN >60 mg/dL; 15. Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than upper limit of normal of the local laboratory or total serum bilirubin > 1.5 times greater than normal upper limit of the local laboratory; 16. Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicaments, drugs or psychoactive substances; 17. Claustrophobia; 18. Females who are pregnant or lactating; 19. Conditions which in the Investigator’s opinion may interfere with the study’s execution or due to which the patient should not participate for safety reasons; 20. Risk of poor patient cooperation; 21. Participation into a clinical study = 2 months before enrolment; 22. Inability or unwillingness to issue the informed consent; 23. Concomitant use of >20 mg daily dose of Simvastatin during the study (in case of patients taking simvastatin > 20 mg daily, the switch to other statins not metabolized by the CYP3A4 could be considered); 24. Concomitant use of Atorvastatin (>80 mg daily); 25. Concomitant use of >1000 mg daily dose of metformin during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate an increase of near maximal hyperaemic myocardial blood flow (MBF ml/min/g) after treatment with ranolazine. Measurement of myocardial perfusion with 13N-ammonia and positron emission tomography; assessment of hyperaemic Myocardial Blood Flow (MBF) following i.v. dipyridamole (0.56 mg/Kg in 4 mins).;Secondary Objective: To demonstrate an increase of Coronary Flow Reserve (hyperaemic MBF /resting MBF = CFR). A decrease of baseline coronary resistance (Mean Arterial Pressure rest/ MBF rest) and of minimal (dipyridamole) coronary resistance (Mean arterial Pressure hyperemia/ MBFhyperemia);Primary end point(s): Hyperemic myocardial blood flow (ml/min/g) before and after treatment with ranolazine;Timepoint(s) of evaluation of this end point: Fourteen days before titration and 120 days after active treatment with Ranolazine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): increase of Coronary Flow Reserve (hyperaemic MBF /resting MBF = CFR). A decrease of baseline coronary resistance (Mean Arterial Pressure rest/ MBF rest) and of minimal (dipyridamole) coronary resistance (Mean arterial Pressure hyperemia/ MBFhyperemia);Timepoint(s) of evaluation of this end point: Fourteen days before titration and 120 days after active treatment with Ranolazine | — |
Countries
Italy
Contacts
Public ContactUfficio Ricerche Cliniche
OSPEDALE SAN RAFFAELE
Outcome results
None listed