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Clinical Trials/EUCTR2019-002202-43-IT
EUCTR2019-002202-43-IT
Active, not recruiting
Phase 1

Effects of empagliflozin on cardiac remodeling and myocardial sympathetic nervous system in diabetic patients affected by chronic heart failure - Empa_MIBG

AOU FEDERICO II0 sites34 target enrollmentOctober 7, 2020
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Conditionsdiabetes mellitus and heart failureMedDRA version: 20.0Level: LLTClassification code 10011949Term: Decompensation cardiacSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsJARDIANCE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSEJARDIANCE - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
diabetes mellitus and heart failure
Sponsor
AOU FEDERICO II
Enrollment
34
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 7, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AOU FEDERICO II

Eligibility Criteria

Inclusion Criteria

  • •Age \=18 years;
  • •Post\-menopausal women, or no\-pregnancy state (documented by pregnancy test);
  • •LVEF \= 40% in at least two consecutive transthoracic echocardiographic evaluations;
  • •Stable clinical conditions (NYHA class II\-III);
  • •Diagnosis of HF since at least 6 months;
  • •Stable optimal pharmacological HF therapy since at least 6 weeks;
  • •Type 2 DM with an indication to treatment with empagliflozin;
  • •Estimated glomerular filtration rate (eGFR) \=30 ml/min/1\.73m2 according to the
  • •Modification of Diet in Renal Disease (MDRD) criteria;
  • •Capability to understand the study procedures and sign the informed consent form.

Exclusion Criteria

  • •Age \=75 years;
  • •Type 1 DM;
  • •Suspected or known liver disease, defined by serum levels of alanine aminotransferase,
  • •aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal;
  • •Planned cardiac surgery (including heart transplantation) or percutaneous coronary
  • •intervention within 3 months;
  • •Acute coronary syndrome, stroke, or transient ischemic attack within 2 months before the
  • •inclusion in the study;
  • •Estimated glomerular filtration (eGFR) \<30 ml/min/1\.73m2 according to the Modification of
  • •Diet in Renal Disease (MDRD) criteria;

Outcomes

Primary Outcomes

Not specified

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