CRTd Responders Optimization
- Conditions
- Heart Failure With Reduced Ejection FractionCardiac DeathHeart Failure
- Registration Number
- NCT04547244
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- heart failure with reduced cardiac pump, NYHA class II/III, indication to receive a CRTd.
- NYHA class IV, previous CRTD implantation, neoplastic disease, inflammatory chronic disease.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celestino Sardu
🇮🇹Napoli, Italy
Celestino Sardu🇮🇹Napoli, Italy