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

Congestive Heart Failure Clinical Trial

— MULTITUDE-HF  

Official title:

Multiparametric Evaluation of Heart Failure in Device-implanted Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501331
• Other study ID #: PTVCARDIO2011_01
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: November 16, 2014
• Start date: December 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• CRTD or ICD (Energen)
RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No