Heart Failure
Conditions
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.
Interventions
None listed
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient must be 18 to 85 years of age inclusive, at the time of signing the informed consent form; 2. Heart failure with ventricular ejection fraction left \<45%; 3. Presence of CRT-D devices in a non-responder patient for cardiac resynchronization 4. NYHA \>II; 5. Resting heart rate \<65 beats per minute; 6. Biventricular pacing \>97%.
Exclusion criteria
1. Age \<18 and \>85 years; 2. Insufficient functional capacity to complete the tests required by the research protocol; 3. Permanent Atrial Fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of acute heart failure episodes | Baseline to 12 months post discharge | Number of worsening HF episodes requiring hospitalization |
| Change in left ventricular ejection fraction (LVEF) | Baseline to 12 months post discharge | An echocardiogram will be performed at specific study visits and LEVF will be measured |
| Echocardiofic changes of diastolic left ventricular function | Baseline to 12 months post discharge | An echocardiogram will be performed at specific study visits and LVESV and LVEDV will be |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline to 12 months post discharge | This is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and quality of life limitation due to HF. Scores range from 0 to 100. For the KCCQ overall summary score, a small but clinically meaningful change is ≥ 5 points. |
| Change in NYHA class | Baseline to 12 months post discharge | Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time. |
Countries
Italy
Contacts
Primary ContactMassimo Saviano, MD
Outcome results
None listed