CRTd Responders Optimization

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction; Cardiac Death; Heart Failure
• Interventions: Other: echocardiographic optimization of CRTd

• Registration Number: NCT04547244
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-06-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Last Update Submitted: 2020-09-07
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2DM patients with CRTd with echocardiographic optimization	echocardiographic optimization of CRTd	In this cohort the T2DM patients with CRTd will receive at follow-up an echocardiography guided optimization of CRTd.

Primary Outcome Measures

Name	Time	Method
CRTd responders rate	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.

Trial Locations

Locations (1)

Celestino Sardu; 🇮🇹 Napoli, Italy