EUCTR2015-004317-24-IT
Active, not recruiting
Phase 1
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)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypertrophic Cardiomyopathy (primitive)
- Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
- Enrollment
- 21
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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