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Clinical Trial Details

Trial ID: L6619
Source ID: NCT01803828
Associated Drug: Tadalafil
Title: REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs
Acronym: RECOGITO
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetic Cardiomyopathy|Diabetes Mellitus Type 2
Interventions: DRUG: Tadalafil|DRUG: Placebo
Outcome Measures: Primary: Change from Baseline in Left Ventricular torsion (°) at 5 months, Change of Left ventricular torsion (°) assessed through CMR with tagging before and after treatment to heart failure and gender differences, time 0, +5 months | Secondary: Change from baseline in cardiac shortening (Strain %) at 5 months, Change of cardiac strain (%) and of parameters of cardiac geometry and performance assessed through CMR with tagging before and after treatment and gender differences, time 0, + 5 months|Change from baseline in Myocardial fibrosis at 5 months, Quantification of Myocardial fibrosis assessed with T1-mapping to establish a new parametersfor the characterization of DCM and treatment efficacy, assessed through CMR before and after treatment and gender differences, time 0, +5 months|Change from baseline in Circulating pro-fibrotic and pro-inflammatory chemokines at 5 months, Assessment of circulating pro-fibrotic and pro-inflammatory chemokines and correlation to torsion, strain and fibrosis at time 0 and after treatment (markers predictors of disease progression and treatment efficacy) and differences in genders, Time 0, +5 months|Peripheral immunological profile, Evaluation of immune function and circulating and cellular angiogenesis mediators predictive of disease progression and PDE5Ai treatment efficacy, time 0 and +5 months|Gender differences in molecular, immunological and cardiac morpho-functional profile., Identify gender differences in molecular, immunological and imaging characterization of the DCM., time 0 and +5 months|Effects of PDE5i on diabetic neuropathy, Identify possible effects of chronic treatment with PDE5i on diabetic neuropathy, time 0 and +5 months|Effects of PDE5i on diabetic nephropathy, Identify possible effects of chronic treatment with PDE5i on diabetic nephropathy, time 0 and +5 months|Effects of PDE5i on Body composition, Evaluation of the effect of PDE5Ai on body composition evaluated by DEXA scan., time 0 and +5 months
Sponsor/Collaborators: Sponsor: University of Roma La Sapienza
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-05
Completion Date: 2019-07
Results First Posted:
Last Update Posted: 2019-07-10
Locations: Dipartimento di Medicina Sperimentale - Sezione di Fisiopatologia Medica - Sapienza Università di Roma, Rome, 00161, Italy
URL: https://clinicaltrials.gov/show/NCT01803828