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CRTd Responders Optimization

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04547244
Enrollment
200
Registered
2020-09-14
Start date
2015-01-01
Completion date
2020-06-01
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERechocardiographic 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.

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
CRTd responders rate12 monthsThe 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026