SHMC

Phase 1

• Conditions: symptomatic hypertrophic cardiomyopathy (SHCM); MedDRA version: 14.1 Level: PT Classification code 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-004507-20-IT
• Lead Sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-08
• Study Completion: 2014-11-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

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: 0
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) • 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/min; 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary study objective will be to demonstrate the efficacy of ranolazine in improving the Exercise capacity in patients affected by SHCM using the V02 peak technique;Secondary Objective: Secondary objectives will be to demonstrate the efficacy of ranolazine on diastolic function, symptomatic status and natriuretic peptide biomarker proBNP in patients affected by SHCM. The assessment of safety by evaluation of adverse events, laboratory findings, the rest standard 12- lead ECG, detection of 24-hour arrhythmic burden by Holter ECG monitoring and physical examination will also be considered a secondary study objectives;Primary end point(s): Evaluation of Exercise Capacity with the V02 peak in patients with SHCM after 5 months of treatment with ranolazine or placebo;Timepoint(s) of evaluation of this end point: after 5 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): E/E' ratio evaluation; Natriuretic peptides biomarkers evaluation (proBNP biomarkers); Symptomatic Status evaluation (Minnesota Living With Heart Failure Questionnaire);Timepoint(s) of evaluation of this end point: after 1 and 5 months