Dynamic EchoCardiographic Optimisation REsponse Study (Studio Sulla Risposta All'Ottimizzazione Dinamica Ecocardiografica)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Change in the number of acute heart failure episodes
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of this study is to evaluate the effects of heart rate optimization and guided A-V and V-V delay from color Doppler echocardiography, in subjects affected by heart failure with reduced ejection fraction and CRT-D device wearers who did not respond to device implantation in clinical, electrophysiological, and other terms.
Investigators
Massimo Saviano
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Eligibility Criteria
Inclusion Criteria
- •Patient must be 18 to 85 years of age inclusive, at the time of signing the informed consent form;
- •Heart failure with ventricular ejection fraction left \<45%;
- •Presence of CRT-D devices in a non-responder patient for cardiac resynchronization
- •Resting heart rate \<65 beats per minute;
- •Biventricular pacing \>97%.
Exclusion Criteria
- •Age \<18 and \>85 years;
- •Insufficient functional capacity to complete the tests required by the research protocol;
- •Permanent Atrial Fibrillation
Outcomes
Primary Outcomes
Change in the number of acute heart failure episodes
Time Frame: Baseline to 12 months post discharge
Number of worsening HF episodes requiring hospitalization
Echocardiofic changes of diastolic left ventricular function
Time Frame: Baseline to 12 months post discharge
An echocardiogram will be performed at specific study visits and LVESV and LVEDV will be
Change in left ventricular ejection fraction (LVEF)
Time Frame: Baseline to 12 months post discharge
An echocardiogram will be performed at specific study visits and LEVF will be measured
Secondary Outcomes
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline to 12 months post discharge)
- Change in NYHA class(Baseline to 12 months post discharge)