Diabetes Mellitus Type 2 Clinical Trial
— RECOGITOOfficial title:
Phase IV Study on New Insights in Remodeling of Diabetic Cardiomyopathy: Gender Difference in Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A
NCT number | NCT01803828 |
Other study ID # | RECOGITO |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | July 2019 |
Verified date | July 2019 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 impact of phosphodiesterase type 5A (PDE5A) inhibition in men. The investigators' study aims to characterize DCM, measuring molecular and neuroendocrine assessment to relate to intramyocardial metabolism and cardiac kinetic. The investigators will perform a randomized, placebo-controlled, double-blind study enrolling 164 diabetic patients (females and males) with DCM, to evaluate gender responses to 6 months of PDE5A inhibitors (PDE5Ai). The investigators' study will describe gender differences in DCM features. The proposed research will test whether PDE5Ai could become a new target for antiremodeling drugs and to discover a molecular pathways affected by this class of drugs and a network of circulating markers for the early diagnosis, monitoring and prediction of response to treatment of DCM.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Dipartimento di Medicina Sperimentale - Sezione di Fisiopatologia Medica - Sapienza Università di Roma | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Effects of PDE5i on diabetic neuropathy | Identify possible effects of chronic treatment with PDE5i on diabetic neuropathy | time 0 and +5 months | |
Secondary | Effects of PDE5i on diabetic nephropathy | Identify possible effects of chronic treatment with PDE5i on diabetic nephropathy | time 0 and +5 months | |
Secondary | Effects of PDE5i on Body composition | Evaluation of the effect of PDE5Ai on body composition evaluated by DEXA scan. | time 0 and +5 months |
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