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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
Sponsor:
Information provided by (Responsible Party):
Andrea M. Isidori, University of Roma La Sapienza

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 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.

Condition or disease Intervention/treatment Phase
Diabetic Cardiomyopathy Diabetes Mellitus Type 2 Drug: Tadalafil Drug: Placebo Phase 4

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. Effects of PDE5i on diabetic neuropathy [ Time Frame: time 0 and +5 months ]
    Identify possible effects of chronic treatment with PDE5i on diabetic neuropathy

  7. Effects of PDE5i on diabetic nephropathy [ Time Frame: time 0 and +5 months ]
    Identify possible effects of chronic treatment with PDE5i on diabetic nephropathy

  8. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Italy
Dipartimento di Medicina Sperimentale - Sezione di Fisiopatologia Medica - Sapienza Università di Roma
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Andrea M Isidori, MD, PhD University of Roma La Sapienza

Additional Information:
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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
Keywords provided by Andrea M. Isidori, University of Roma La Sapienza:
Diabetic Cardiomyopathy
Genders
Phosphodiesterase 5A inhibitors
endothelial dysfunction
inflammation
diabetic complications
Additional relevant MeSH terms:
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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