REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs (RECOGITO)
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ClinicalTrials.gov Identifier: NCT01803828 |
Recruitment Status :
Completed
First Posted : March 4, 2013
Last Update Posted : July 10, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Cardiomyopathy Diabetes Mellitus Type 2 | Drug: Tadalafil Drug: Placebo | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | May 2014 |
Actual Primary Completion Date : | January 2019 |
Actual Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Drug Group (Tadalafil)
Tadalafil 20 mg
|
Drug: Tadalafil
20 mg/die (1 capsule)
Other Name: Cialis 20 mg |
Placebo Comparator: Placebo Group (PLC)
Placebo 20 mg
|
Drug: Placebo
Placebo 20 mg/die (1 capsule) |
- Change from Baseline in Left Ventricular torsion (°) at 5 months [ Time Frame: time 0, +5 months ]Change of Left ventricular torsion (°) assessed through CMR with tagging before and after treatment to heart failure and gender differences
- Change from baseline in cardiac shortening (Strain %) at 5 months [ Time Frame: time 0, + 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
- Change from baseline in Myocardial fibrosis at 5 months [ Time Frame: time 0, +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
- Change from baseline in Circulating pro-fibrotic and pro-inflammatory chemokines at 5 months [ Time Frame: Time 0, +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
- Peripheral immunological profile [ Time Frame: time 0 and +5 months ]Evaluation of immune function and circulating and cellular angiogenesis mediators predictive of disease progression and PDE5Ai treatment efficacy
- Gender differences in molecular, immunological and cardiac morpho-functional profile. [ Time Frame: time 0 and +5 months ]Identify gender differences in molecular, immunological and imaging characterization of the DCM.
- Effects of PDE5i on diabetic neuropathy [ Time Frame: time 0 and +5 months ]Identify possible effects of chronic treatment with PDE5i on diabetic neuropathy
- Effects of PDE5i on diabetic nephropathy [ Time Frame: time 0 and +5 months ]Identify possible effects of chronic treatment with PDE5i on diabetic nephropathy
- Effects of PDE5i on Body composition [ Time Frame: time 0 and +5 months ]Evaluation of the effect of PDE5Ai on body composition evaluated by DEXA scan.

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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803828
Italy | |
Dipartimento di Medicina Sperimentale - Sezione di Fisiopatologia Medica - Sapienza Università di Roma | |
Rome, Italy, 00161 |
Principal Investigator: | Andrea M Isidori, MD, PhD | University of Roma La Sapienza |
Additional Information:
Responsible Party: | Andrea M. Isidori, Professor, University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT01803828 History of Changes |
Other Study ID Numbers: |
RECOGITO |
First Posted: | March 4, 2013 Key Record Dates |
Last Update Posted: | July 10, 2019 |
Last Verified: | July 2019 |
Diabetic Cardiomyopathy Genders Phosphodiesterase 5A inhibitors |
endothelial dysfunction inflammation diabetic complications |
Cardiomyopathies Diabetic Cardiomyopathies Diabetes Mellitus, Type 2 Heart Diseases Cardiovascular Diseases Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Diabetes Complications Tadalafil Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |