Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients (MULTITUDE-HF)

Multiparametric Evaluation of Heart Failure in Device-implanted Patients.

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: CRTD or ICD (Energen)

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
  • Rome, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients implanted with an Energen device or successor using the RRT diagnostic tool

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RRT diagnostic tool; Patients implanted with an Energen device or successor.	Device: CRTD or ICD (Energen); RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms.	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)	Respiratory rate changes (maximum, median and minimum values) before the 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	24 months
Correlation of RRT with appropriate ICD therapy (ATP or Shock)	Respiratory rate changes (maximum, median and minimum values) before the 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	24 months
Correlation of RRT with atrial and ventricular arrhythmias	Respiratory rate changes (maximum, median and minimum values) before the 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	24 months

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata
• Investigators: Principal Investigator: Giovanni B Forleo, MD, PhD, University of Rome Tor Vergata; Principal Investigator: Luca Santini, MD, PhD, University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (Estimate): December 29, 2011

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 16, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Cardiac Resynchronization Therapy; Congestive Heart Failure; Internal Cardioverter Defibrillators
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PTVCARDIO2011_01