Endocrine cardiomyophaty: Response to cyclic GMP PDE5 inhibitors in Acromegaly cardiomyopathy
- Conditions
- AcromegalyMedDRA version: 20.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2015-004498-34-IT
- Lead Sponsor
- MBERTO I - POLICLINICO DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 15
age>18 yrs; patients (men and women) with previous diagnosis of Acromegaly, surgically and/or clinically treated according to current
guidelines, with stable parameters of Acromegaly disease in the last 3 months, and with concomitant cardiac hypertrophy and/or diastolic
dysfunction developed independently of Acromegaly care and detected by 2D echocardiography
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
congenital or valvular cardiomyopathy, recent ischemic heart disease or revascularization after a myocardical infarction (MI), and
contraindications to tadalafil 20 mg use (hypersensitivity to tadalafil, nitrates use, severe cardiovascular disorders (in the past 6 months) such as unstable angina or severe heart failure (NYHA II or III), or a stroke or myocardial infarction, heart rhythm problems, blood pressure <90/50 mmHg, severe hepatic or kidney impairment, and known hereditary degenerative retinal disorders such as retinitis pigmentosa, history of NAION)
and to MRI examination
- pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method