EUCTR2015-004317-24-IT进行中（未招募）1 期
A pilot study to assess Coronary Flow Reserve and post-vasodilatatory Myocardial Blood Flow (post-Dipi gMBF), measured by 13N-NH3 PET/CT, before and after a six months-long treatment with the ACE-inhibitor Perindopril, in moderate and high-risk HCM patients”A multicentric, interventional, open label, perspective-design, single-arm, pilot” clinical Study. - CARAPaCe (CoronAry Reserve After Perindopril in hypertophic Cardiomyopathy)
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
研究概览
简要总结
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研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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.
- •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 < 2.1 mL/min*gr, as assessed
- •by 13N-NH3 PET/CT myocardial perfusion scan at
- •baseline (B-PET/CT).
- •9. Stable sinus rhythm, as assessed by B-ECG.
- •10. Clear ability to understand the significance and the procedures of the Protocol and to sign a legally valid
- •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 21
- •F.1.3 Elderly (>=65 years) no
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排除标准
- •1. Women, who are pregnant or lactating
- •2. Women, i in childbearing age, not using an adequatecontraception (i.e., techniques having Pearl index<2)
- •3. Clinical evidence or previous clinical story of diseasescausing myocardial hypertrophy or similar
- •phenotypes:
- •a. Aortic stenosis
- •b. Cardiac amyloidosis
- •c. hemochromatosis
- •d. storage diseases
- •4. Coronary Artery Disease :
- •a. previous coronarography, assessing 1 or
- •more stenosis >70% of major epicardial
- •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 (<30 days old)
- •coronarography, negative for stenosis >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 <110 mmHg systolic measured at EV (Enrollment Visit)
- •10. LV outflow tract obstruction, with peak of ejection
- •gradient >50 mmHg measured at rest, as assed by
- •11. Prior surgical septal myectomy or alcoholic ablation;
- •12. LV systolic dysfunction with EF <50% as assessed
- •13. Evidence for electric ventricular conduction
- •abnormalities such as LBBB, RBBB, WPW, AV blocks,Long QT, as assessed by B-ECG.
- •14. Body mass index >32 Kg/m2
- •15. Clinical evidence or clinical story for Diabetes
- •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< 60 mL/min estimated by MDRD equation and by B-BT data.
- •19. Clinical story for chronic liver disease with
- •insufficiency > 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
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