CRTd Responders Optimization

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547244
• Other study ID #: 08.09.20
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: June 1, 2020

Study information

• Verified date: September 2020
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Death
• Death
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• echocardiographic optimization of CRTd
the patients after the implant of CRTd and during the follow-up will receive an echocardiography to optimize the atrio-ventricular and inter-ventricular delay, and to improve the effects of CRTd.

Locations

Country	Name	City	State
Italy	Celestino Sardu	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRTd responders rate	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.	12 months