CRTd Responders Optimization

NCT04547244 | Completed

• 1 other identifier: 08.09.20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

echocardiographic optimization of CRTd OTHER

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.

T2DM patients with CRTd with echocardiographic optimization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged more than 18 and less than 75 affected by chronic heart failure in NYHA class II/III with reduced cardiac pump and indication to receive a CRTd.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Celestino Sardu

Napoli, Italy

Location

Related Publications (1)

• Sardu C, Paolisso P, Ducceschi V, Santamaria M, Sacra C, Massetti M, Ruocco A, Marfella R. Cardiac resynchronization therapy and its effects in patients with type 2 DIAbetes mellitus OPTimized in automatic vs. echo guided approach. Data from the DIA-OPTA investigators. Cardiovasc Diabetol. 2020 Nov 28;19(1):202. doi: 10.1186/s12933-020-01180-8.

  PMID: 33248462 DERIVED

MeSH Terms

Conditions

Heart Failure; Death

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: January 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

IT (1)