Aortic stenosis MedDRA version: 13.1 Level: PT Classification code 10002918 Term: Aortic valve stenosis System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Ranexa
Product Name: Ranexa
Pharmaceutical Form: Tablet
INN or Proposed INN: Ranolazine
CAS Number: 95635-55-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
A. MENARINI PHARMA U.K.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Moderate-severe aortic stenos is ( AVA 36mmHg, mean PG >20mmHg and abnormal aortic valve morphology) 2. Evidence of diastolic dysfunction on echocardiography (MV inflow and or TDI) or LVH (maximum wall thickness >13mm) 3. Asymptomatic (No angina, syncope, heart failure or more than mild dyspnoea (NYHA class 18years 5. Willing to consent 6. Ability to perform treadmill exercise 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Planned aortic valve replacement within study period 2) History of coronary artery bypass grafts, myocardial infarction, angiographic coronary artery disease (>50% luminal stenosis if previously undertaken) 3) Atrial fibrillation 4) Severe Asthma 5) Severe renal impairment estimated glomerular filtration rate 470ms 10) Hypersensitivity to Ranolazine 11) Females of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does Ranolazine improve relaxation of the heart and increase blood supply to the heart in patients with narrowing of the aortic valve?;Secondary Objective: Does Ranolazine increase the patients exercise capacity measured using cardiopulmonary exercise testing?;Primary end point(s): Peak diastolic strain rate (MRI Tagging) | — |
Countries
United Kingdom
Outcome results
None listed