Effect of Ranolazine in patients with impaired left ventricular function due to their stable angina for the presence of an abnormal ventricular contractile status that is maintained in the post-systolic

Phase 1

• Conditions: Stable angina with normal ejection fraction; MedDRA version: 20.0Level: PTClassification code 10002383Term: Angina pectorisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-003149-24-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-27
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

•Male and female gender (females of childbearing potential must be using adequate 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 diagnosis of stable effort chronic angina based on clinical symptoms (angina; ischemic equivalents) or ischemia tests (stress ECG/stress-exercise echocardiography/Miocardial perfusion scintigraphy) independently from baseline antianginal therapy.
•Patients aged = 18 years;
•Patients with normal LV ejection fraction (EF) without LV wall motion abnormalities detected by standard echocardiography or if abnormalities are present, the post systolic thickening must be present in a different, non-contiguous segment;
•Patients with post systolic thickening independently from baseline antianginal therapy, defined as the presence of SI = 50%, 5 min. during and/or after the supine bicycle speckle tracking echo stress (speckle tracking) test performed by using the standard Bruce protocol;
•Presence of sinus rhythm;
•Written informed consent prior to enrolment into the study.
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 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

•Females of childbearing potential not using adequate contraceptive precautions;
•Presence of unstable angina, left main trunk disease, previous myocardial infarction, previous cardiac surgery, artificial pacemaker, non-sinus rhythm, significant valvular heart disease;
•Presence of congestive heart failure;
•Presence of Chronic Obstructive Airways Disease;
•Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone). Grapefruit juice is also a potent CYP3A4 inhibitor.
•Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
•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; BUN >60 mg/dL;
•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 (>350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances;
•Females who are pregnant or lactating;
•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 an exercise stress test.

Study & Design

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