Clinical trial: Endocrine Cardiomyopathy in Cushing Syndrome: Response to Cyclic GMP PDE5 inhibitOrs (NCT02611258)

Eligibility criteria:
Inclusion Criteria:

          -  age>18 yrs;

          -  patients (men and women) with previous diagnosis of Cushing Syndrome (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;

          -  urinary free cortisol (UFC) levels in the normal range for sex and age;

          -  normal blood pressure or controlled hypertension

        Exclusion Criteria:

          -  use of thiazolidinediones, or spironolactone; nitrates, doxazosin, terazosin e
             prazosin;

          -  current use of PDE5 inhibitors or previous (wash out of two months at least);

          -  congenital or valvular cardiomyopathy;

          -  recent ischemic heart disease or revascularization after a myocardial infarction (MI);

          -  contraindications to tadalafil use (hypersensitivity to tadalafil, nitrates use,
             severe cardiovascular disorders such as unstable angina or severe heart failure,
             severe hepatic impairment, blood pressure <90/50 mmHg, recent history of stroke or
             myocardial infarction and known hereditary degenerative retinal disorders such as
             retinitis pigmentosa);

          -  contraindications to CMR.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 47-year-old man comes to the office due to weight gain and fatigue.  He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father.  Blood pressure is 165/90 mm Hg and pulse is 85/min.  On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities.  Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit.  Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels.  Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome.

Patient description (patient's own words): I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome.

Does the patient match the trial criteria? 0