CRTd Responders Optimization

• Sponsor: University of Campania "Luigi Vanvitelli" (Other)
• Overall Status: Completed
• CT.gov ID: NCT04547244
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 65
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Heart Failure With Reduced Ejection Fraction; Cardiac Death	Other: echocardiographic optimization of CRTd

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Optimization of Cardiac Resynchronization Therapy and Its Effects in Patients With Type 2 Diabetes Mellitus: Automatic Optimization vs. Echocardiographic Guided Optimization.
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celestino Sardu	Napoli		Italy

Sponsors and Collaborators

• University of Campania "Luigi Vanvitelli"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celestino Sardu, researcher, University of Campania "Luigi Vanvitelli"
• ClinicalTrials.gov Identifier: NCT04547244
• Other Study ID Numbers: 08.09.20
• First Posted: Sep 14, 2020
• Last Update Posted: Sep 14, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure; Death

Study Results

No Results Posted as of Sep 14, 2020