Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs

Phase 1

• Conditions: Cushing’s Syndrome; MedDRA version: 20.0Level: PTClassification code 10011652Term: Cushing's syndromeSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-004497-15-IT
• Lead Sponsor: MBERTO I - POLICLINICO DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

age>18 yrs; patients (men and women) with previous diagnosis of CS, surgically and/or clinically treated according to current guidelines, with stable parameters of CS disease in the last 3 months, and with concomitant cardiac hypertrophy and/or diastolic dysfunction developed independently of CS 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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

congenital or valvular cardiomyopathy, recent ischemic heart disease or revascularization after a myocardical infarction (MI), and contraindications to tadalafil 20 mg use and to MRI examination

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified