Hypertrophic Cardiomyopathy (primitive) MedDRA version: 20.0 Level: PT Classification code 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: PROCAPTAN - 10 MG COMPRESSE RIVESTITE CON FILM 60 COMPRESSE IN CONTENITORE PER COMPRESSE PP
Product Name: procaptan
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PERINDOPRIL
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age in the range 18-60 2. Availability of a 12-lead rest-ECG, performed not earlier than 60 days prior to enrollment visit (EV). This is called B-ECG (Baseline-ECG), in the following text. 3. Availability of a 2-D Doppler echocardiogram, performed at rest, not earlier than 60 days before of EV. This is called B-ECO (Baseline - Ecocardiography in the following text. 4. Availability of a 13N-NH3 PET/CT myocardial perfusion scan for measurement of Myocardial Blood Flow (MBF), global and regional, performed not earlier than 60 days before of enrollment visit, at one or the other of involved clinical trial center. This is called B-PET/CT (Baseline-Positron Emission Tomography/Computed Tomography), in the following text 5. Availability of lab tests (including at least: a. Hematocrit and complete blood count (CBC) b. blood urea nitrogen (BUN) c. serum creatinine, d. blood glucose, e. serum potassium ion performed not earlier than 60 days before of enrollment visit. This is called “Baseline-Blood Tests” (B-BT), in the following text. 17 6. Fulfillment of 2D-echocardiographyc (as assessed by B-ECO), and clinical criteria for diagnosis of HCM according to the ACCF/AHA Guideline (2011) for diagnosis of HCM: a. maximum LV wall thickness >1.5 cm b. not-dilated LV cavity in the absence of clinical evidence for any other cardiovascular or systemic etiology, justifying the degree of myocardial hypertrophy actually seen (e.g., arterial hypertension, aortic valve stenosis, cardiac amyloidosis, metabolic storage diseases, as detailed in the exclusion criteria). 7. Absence of severe, resting LV outflow tract obstruction (peak gradient, measured at rest, >50 mmHg), as assessed by B-ECO. 8. Global Post-Dipi gMBF =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women, who are pregnant or lactating 2. Women, i in childbearing age, not using an adequatecontraception (i.e., techniques having Pearl index70% of major epicardial arteries b. Clinical story for previous PTCA c. Clinical story for previous CABG. 5. Evidence for fixed or inducible regional defect of perfusion of LV, as assessed by B-PET/CT, suggesting CAD, unless recent (70% in any of the major epicardial arteries, is available. 6. Evidence for valvular heart disease (particularly for aortic stenosis), as assessed by B-ECO. 7. Previous clinical story for arterial hypertension, requiring antihypertensive medication 8. Arterial pressure >145 mmHg systolic and/or >90 mmHg diastolic measured at EV 9. Arterial pressure 50 mmHg measured at rest, as assed by B-ECO 11. Prior surgical septal myectomy or alcoholic ablation; 12. LV systolic dysfunction with EF 32 Kg/m2 15. Clinical evidence or clinical story for Diabetes Mellitus 16. Clinical story for vasculitis or connective tissue disease (AR, LES, SS, MCTD, Churg Strauss vasculitis, ANCA-linked vasculitis, polyarterits nodosa, temporal arteritis, Takayasu disease, etc.) 17. Clinical story for cancer of any kind unless nonmelanoma skin cancers 18. GFR class A Child-Pugh 20. Present evidence or previous story of neurologic diseases (cerebrovascular, neurodegenerative, demielinating) 21. Clinical story for psychiatric disorders or administration (previous or present) of psychotropic drugs (unless minor tranquillizers or hypnotics) 22. Clinical story for psychotropic drugs abuse or addiction, or for alcohol abuse/addiction 23. Any contraindication to the administration of Perindopril,such as: a. Hypersensitivity to Perindopril or other ACE-inhibitors b. Clinical story for previous angioedema due to administration of ACE-inhibitors c. Clinical story for idiopathic or hereditary angioedema d. Aortic valve stenosis e. Mitral valve stenosis f. Liver failure > class A Child Pugh. g. GFR50 mmHg measured at rest (assessed by B-ECO) i. Concurrent therapy with diuretics j. Concurrent therapy with potassium supplements or potassium sparing diuretics k. Concurrent therapy with lithium salts 24. Any contraindication to the administration of Dipyridamole (Persantyn®), particularly: a. Individual hypersensitivity to the active substance or excipients of medicinal product b. Severe asthma 25. Any contraindication to the administration of Aminophilline (Aminomal®), particularly: a. Individual hypersensitivity to the active substance or excipients of the medicinal product (Aminomal®) b. Individual hypersensitivity to other methylxanthines, and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The comparison of global Myocardial Blood Flow g(MBF), after vasodilation by administration of Dipyridamole, (post-Dipi gMBF), measured by 13N-NH3 PET/CT, before and after a six month long treatment with Perindoprilarginine, in a sample of HCM patients belonging to moderate or high risk groups according to baseline post- Dipi gMBF <2.1 ml/min*gr.;Secondary Objective: The comparison of global Myocardial Blood Flow g(MBF) at rest before and after a six month long treatment with Perindopril-arginine, in a sample of HCM patients belonging to moderate or high risk groups according to baseline post-Dipi gMBF <2.1 ml/min*gr. 2- The comparison of Coronary Flow Reserve (CFR), before and after a six month-long treatment with Perindopril-arginine, in a sample of HCM patients belonging to moderate or high risk groups according to baseline post-Dipi gMBF <2.1 ml/min*gr. 3- The assessment of safety of administration of Perindopril-arginine in a sample of HCM patients belonging to moderate or high risk groups according to baseline post-Dipi gMBF <2.1 ml/min*gr.;Primary end point(s): Change of post-vasodilatation global Myocardial Blood Flow (post-Dipi gMBF), calculated as the difference between post-Dipi gMBF at the end of a six months-long treatment period with the ACE-inhibitor Perindopril-arginine and baseline values (measurements made by 13N-NH3 PET/CT);Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Change of Myocardial Blood Flow at rest (rest-gMBF), calculated as the difference between rest-gMBF at the end of a six months-long treatment period with the ACE-inhibitor Perindopril-arginine and baseline values (measurements made by 13N-NH3 PET/CT) 2-Change of Coronary Flow reserve (CFR, i.e., ratio between post-Dipi gMBF and rest-gMBF), calculated as difference between CRF at the end of a six months-long treatment period with the ACE-inhibitor Perindopril-arginine and baseline values (measurements made by 13N-NH3 PET/CT) 3-Recognition and classification of Adverse Events and Adverse Drug Reactions during treatment period with Perindopril-arginine. ;Timepoint(s) of evaluation of this end point: 6 monyhs | — |
Countries
Italy
Contacts
Public ContactSODC Medicina Nucleare- servizi inf
Azienda ospedaliero-universitaria careggi
Outcome results
None listed