SHCM

Conditions: symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 17.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-004507-20-DE

Lead Sponsor: Menarini International Operations Luxembourg S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

• Male and female gender;
• Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner);
• Patients which fulfil conventional echocardiographic criteria for the diagnosis of SHCM: Maximum LV wall thickness >= 1.5 cm;
• Patients aged > 18 years;
• Patients with exertion symptoms and functional limitation (angina and or HF NYHA II-III);
• Presence of sinus rhythm;
• Peak V02 < 75% of predicted for age and gender;
• Absence of resting LV outflow tract obstruction (peak gradient < 30 mmHg);
• Written informed consent prior to enrolment into the study
• Persons capable to understand the nature, significance and implications of the clinical trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

• Females of childbearing potential not using adequate contraceptive precautions;
• Females who are pregnant or lactating;
• Presence of known coronary artery disease (CAD);
• Presence of Chronic Obstructive Airways Disease;
• Concomitant administration of potent CYP3A4 inhibitors
• Concomitant administration of dronedarone Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone, or other QT-prolonging drugs;
• Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John’s Wort)
•Concomitant use of > 1000 mg daily dose of metformin during the study
•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).
• Patients with QTc at baseline >= 500 ms;
• Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator’s judgment;
• Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.);
• Severe renal impairment defined as GFR < 29 mL/minor creatinine level > 2.5 mg/dL; GFR must always be calculated;
• Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper
limit;
• Dementia, psychosis, alcoholism (>280 g ethanol/week for male or >140 g ethanol/week for female patients) or chronic abuse of medicines, drugs or
psychoactive substances;
• 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;
• Risk of low patient cooperation;
• Inability or unwillingness to issue the informed consent;
• Inability to perform a cardiopulmonary test;
• Lactose intolerance;
• Hypersensitivity to ranolazine or one of the excipients.