Multiparametric Evaluation of Heart Failure in Device-implanted Patients.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure
- Sponsor
- University of Rome Tor Vergata
- Enrollment
- 180
- Primary Endpoint
- Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This may result in early detection of imminent decompensation at a presymptomatic stage. The study will assess the respiratory trends correlation with clinically relevant heart failure events.
Investigators
Giovanni B Forleo
MD, PhD
University of Rome Tor Vergata
Eligibility Criteria
Inclusion Criteria
- •Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted within the past 45 days with a Energen device or successor
- •Able to provide written informed consent
Exclusion Criteria
- •Life expectancy \<12 months
- •Anticipated non-compliance with the follow-up scheme
- •Moderate to severe Chronic Obstructive Pulmonary Disease
- •Primary pulmonary hypertension
Outcomes
Primary Outcomes
Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms.
Time Frame: 24 months
Respiratory rate changes (maximum, median and minimum values) before a primary event (3-, 2-, 1-week before and on the day of the event) will be compared to those at baseline (6 weeks prior the event). Pts with less than 30-day of RR data or events without sufficient baseline will be excluded from the analysis
Secondary Outcomes
- Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)(24 months)
- Correlation of RRT with appropriate ICD therapy (ATP or Shock)(24 months)
- Correlation of RRT with atrial and ventricular arrhythmias(24 months)