CRTd Responders Optimization

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Cardiac Death; Heart Failure With Reduced Ejection Fraction; Heart Failure

Treatments: Other: echocardiographic optimization of CRTd

Study type: Observational

Funder types: Other

Identifiers

NCT04547244

08.09.20

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

T2DM patients with CRTd with automatic optimization

Description:

In this cohort the T2DM patients with CRTd will receive at follow-up an automatic optimization of CRTd.

T2DM patients with CRTd with echocardiographic optimization

Description:

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

Treatment:

Other: echocardiographic optimization of CRTd