Diastolic dysfunction after acute myocardial infarction MedDRA version: 20.1 Level: LLT Classification code 10076396 Term: Heart failure with preserved ejection fraction System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Entresto
Pharmaceutical Form: Tablet
INN or Proposed INN: Entresto
Other descriptive name: SACUBITRIL VALSARTAN
Concentration unit: mg milligram(s)
Concentration type: range
Concentration
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria: 1. Documented ST segment or non ST segment elevation AMI, 2. Complete revascularization. 3. Age >=50 years 4. LVEF >=45% on echocardiography performed within 72 hours of the AMI. 5. Diastolic dysfunction defined as: Ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e’) ratio > 8 and LA dilatation (LA volume index>34 mL/m2). 6. Signed informed consent 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 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
Exclusion criteria
Exclusion criteria: 1. Known history of cardiomyopathy, and or moderate/severe valvular heart disease, 2. Severe obstructive or restrictive pulmonary disease, 3. Inability to perform exercise testing/ inadequate acoustic windows on echocardiography, 4. Class I indication for an angiotensin converting enzyme inhibitor. 5. A systolic blood pressure of less than 100 mm Hg at screening 6. An estimated glomerular filtration rate (eGFR) below 30 ml per minute per 1.73 m2 of body-surface area at any time, 7. A serum potassium level of more than 5.2 mmol per liter at screening, 8. A history of angioedema or unacceptable side effects during receipt of angiotensin converting enzyme inhibitor or angiotensin receptor blocker 9. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 6 months treatment with LCZ696 compared with placebo on ratio of pulmonary capillary wedge pressure/cardiac index during exercise in patients with a recent AMI and Doppler echocardiographic signs of diastolic dysfunction and preserved systolic function. ;Secondary Objective: To assess the effect of 6 months treatment with LCZ696 compared with placebo in patients with a recent AMI, diastolic dysfunction and preserved systolic function on: 1. Cardiac fibrosis assessed on cardiac magnetic resonance imaging, 2. The ST2 cardiac biomarker 3. Left atrial size and function ;Primary end point(s): Ratio of pulmonary capillary wedge pressure to cardiac index at peak exercise after 6 months treatment with LCZ696 or placebo. ;Timepoint(s) of evaluation of this end point: After 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Amount of hyperenhancement on cardiac MRI using a semiquantitative assessment of late gadolinium hyperenhacement in a 17 segment model of the LV. 2. Biomarker ST2 concentration. 3. Left atrial volume and left atrial emptying fraction by echocardiography and MRI at rest. ;Timepoint(s) of evaluation of this end point: After 26 weeks. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Cardiology
Odense University Hospital
Outcome results
None listed