Status:
COMPLETED
REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Diabetic Cardiomyopathy
Diabetes Mellitus Type 2
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
Brief Summary
Pathophysiology of diabetic cardiomyopathy (DCM) is yet unclear and gender differences at baseline and a specific treatment have not been indicated. The investigators already demonstrated the positive...
Detailed Description
DCM is yet unclear and gender differences at baseline and a specific treatment have not been indicated. The study aims to characterize DCM, measuring molecular and neuroendocrine assessment to relate ...
Eligibility Criteria
Inclusion
- age 45-80 years;
- Diagnosis of Type 2 Diabetes from at least 3 years;
- HbA1c \< 10%;
- normal blood pressure or controlled hypertension;
- BMI \< 40;
- SIV ≥ 11 mm men, ≥ 10 women and/or diastolic dysfunction (PW-doppler and TDI)
Exclusion
- current use of PDE5 inhibitors;
- congenital or valvular cardiomyopathy;
- ischemic heart disease;
- proliferative retinopathy;
- 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 imaging with mdc (patients with implant such as cardiac pacemakers, insulin pumps, neurostimulators and cochlear implants, or metallic fragments, clips or devices, or severe renal failure with GFR \< 30mL/min/1.73 m2);
- cronic or acute atrial fibrillation.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01803828
Start Date
May 1 2014
End Date
July 1 2019
Last Update
July 10 2019
Active Locations (1)
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1
Dipartimento di Medicina Sperimentale - Sezione di Fisiopatologia Medica - Sapienza Università di Roma
Rome, Italy, 00161