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Clinical Trials/NCT04547244
NCT04547244
Completed
Not Applicable

Optimization of Cardiac Resynchronization Therapy and Its Effects in Patients With Type 2 Diabetes Mellitus: Automatic Optimization vs. Echocardiographic Guided Optimization.

University of Campania "Luigi Vanvitelli"1 site in 1 country200 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Campania "Luigi Vanvitelli"
Enrollment
200
Locations
1
Primary Endpoint
CRTd responders rate
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Suboptimal optimization of atrio-ventricular (AV) and inter-ventricular (VV) timings could affect the clinical response of CRTd in T2DM patients. Thus, authors hypothesize that automatic sensor guided CRTd optimization could ameliorate clinical outcomes in patients with T2DM. However, authors will evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiographic guided approach.Authors will conduct a prospective, multicenter study to recruit, from October 2016 to June 2019, patients with T2DM and heart failure (HF) candidate to receive a CRTd. After CRTd the patients will be optimized via automatic vs. echocardiographic guided approach.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
June 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Celestino Sardu

researcher

University of Campania "Luigi Vanvitelli"

Eligibility Criteria

Inclusion Criteria

  • heart failure with reduced cardiac pump, NYHA class II/III, indication to receive a CRTd.

Exclusion Criteria

  • NYHA class IV, previous CRTD implantation, neoplastic disease, inflammatory chronic disease.

Outcomes

Primary Outcomes

CRTd responders rate

Time Frame: 12 months

The authors will evaluate the CRTd responders rate in terms of patients that will experience the reduction of NYHA class, improvement of HF symptoms, and improvement of left ventricle ejection fraction.

Study Sites (1)

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