hypertrophic cardiomyopathy
Conditions
Interventions
Trade Name: Entresto 50 mg (24 mg/26 mg)
Pharmaceutical Form: Tablet
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Concentration unit: mg milligram(s)
Concentr
Sponsors
University Hospital Regensburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults =18 years of age 2) Confirmed diagnosis of hypertrophic cardiomyopathy 3) Agreement to be a participant in the study protocol and willing/able to return for follow-up 4) Able to provide written informed consent 5) In women of childbearing age: Willingness to use a highly effective contraceptive method (failure rate per year =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1) Less than 3 months post septal reduction therapy (surgery or catheter-based intervention) 2) Clinical cardiac decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms. 3) Resting blood pressure > 180/100 mm Hg or systolic blood pressure 50 mmHg. 7) Left ventricular ejection fraction 5.2 mmol/l). 10) Renal insufficiency with a glomerular filtration rate 40 kg/m2). 14) History of exercise induced syncope or sustained ventricular arrhythmias. 15) Inability to exercise due to orthopaedic or other non-cardiovascular limitations. 16) Use of other investigational drugs at the time of enrolment. 17) Concomitant treatment with aliskiren-containing drugs; discontinuation of treatment with aliskiren-containing drugs is required before initiation of ARNI (Sacubitril/Valsartan) 18) History of angiotensin converting inhibitors- or angiotensin receptor blockers-induced angioedema or history of hereditary or idiopathic angioedema. 19) Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2x ULN, severe hepatic insuffucuency (classification Child Pugh C), biliary cirrhosis, cholestasis (current or anamnesic evidence), history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt 20) Any surgical or medical condition that in the opinion of the investigator may place the patient at higher risk from his/her participation in the study or is likely to prevent the patient from complying with the requirements of the study or completing the study. 21) History of noncompliance to medical regimens and patients who are considered potentially unreliable. 22) History or evidence of drug or alcohol abuse within the past 12 months. 23) History of malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin or localized prostate cancer), treated or untreated, within the past 2 years, regardless of whether there is evidence of local recurrence or metastases. 24) Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and AF or atrial flutter with a resting ventricular rate >110 beats per minute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare peak oxygen consumption by cardiopulmonary exercise testing before and after administration of ARNI (Sacubitril/Valsartan);Secondary Objective: -Quantitatively determine effects of the intervention on the magnitude or distribution of cardiac hypertrophy or left ventricular chamber dimensions, degree of left ventricular outflow obstruction, systolic or diastolic function, left ventricular wall motion, and fibrosis using echocardiography and cardiac magnetic resonance imaging -Compare injury and stretch activation markers (i.e. Creatine kinase, Creatine kinase – MB, and NT-proBNP) before and after administration of ARNI (Sacubitril/Valsartan) -Administer quality of life questionnaires before and after the intervention ;Primary end point(s): Change in exercise tolerance (i.e. peak oxygen consumption) in cardiopulmonary exercise testing;Timepoint(s) of evaluation of this end point: baseline, after 4 months and after 7 months (follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Magnitude or distribution of cardiac hypertrophy or left ventricular chamber dimensions (2) Degree of left ventricular outflow obstruction (3) Systolic or diastolic function (4) Left ventricular wall motion (5) Injury and stretch activation markers (i.e. Creatine kinase, Creatine kinase – MB, and NT-proBNP) (6) Quality of life indicators (SF12-v2-, Minnesota Living with Heart Failure-, and Hospital Anxiety and Depression-questionnaires);Timepoint(s) of evaluation of this end point: baseline, after 4 months and after 7 months (follow-up) | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
University Hospital Regensburg, Department of Internal Medicine II
Outcome results
None listed