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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT03953989
Date of registration: 13/05/2019
Prospective Registration: No
Primary sponsor: IRCCS San Raffaele
Public title: Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy
Scientific title: A Pilot Study Assessing the Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy
Date of first enrolment: October 2016
Target sample size: 26
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03953989
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Italy
Contacts
Name:     Paolo Camici, MD
Address: 
Telephone:
Email:
Affiliation:  IRCCS Ospedale san Raffaele
Key inclusion & exclusion criteria

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, class I antiarrhythmics (see appendix 4)
or other QT-prolonging drugs; stable treatment with amiodarone is permitted;

- Patients with QTc (Bazett's formula) at baseline = 450 ms males; =470 msec females;

- 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/1.73m2 or creatinine level > 2.5
mg/dL or BUN >60 mg/dL;

- Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT
> 2 times greater than normal upper limit of the local laboratory or total serum
bilirubin > 1.5 times greater than normal upper limit of the local laboratory;

- Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicaments,
drugs or psychoactive substances;

- Claustrophobia;

- Females who are pregnant or lactating;

- Conditions that 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 poor patient cooperation;

- Participation in a clinical study = 2 months before enrolment;

- Inability or unwillingness to issue the informed consent;

- 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);

- Concomitant use of Atorvastatin (> 80 mg daily)

- Concomitant use of > 1000 mg daily dose of metformin during the study



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
HCM - Hypertrophic Non-Obstructive Cardiomyopathy
Intervention(s)
Drug: Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die
Primary Outcome(s)
Coronary Flow Reserve (hyperaemic MBF /resting MBF = CFR). [Time Frame: At baseline and after 4 months of treatment]
Coronary resistance [Time Frame: At baseline and after 4 months of treatment]
Myocardial Blood Flow during hyperemia ml/min/g [Time Frame: At baseline and after 4 months of treatment]
Secondary Outcome(s)
Symptoms [Time Frame: through 4 month of treatment]
Secondary ID(s)
HCMRanIT001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Menarini International Operations Luxembourg SA
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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