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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Giovanni B Forleo, University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT01501331
First received: December 6, 2011
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Device: CRTD or ICD (Energen)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multiparametric Evaluation of Heart Failure in Device-implanted Patients.

Resource links provided by NLM:


Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • Prediction by RRT of cardiovascular death or rehospitalization for worsening of heart failure symptoms. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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


  • Correlation of RRT with appropriate ICD therapy (ATP or Shock) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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


  • Correlation of RRT with atrial and ventricular arrhythmias [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 180
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501331

Locations
Italy
Milan, Italy
Rome, Italy
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Giovanni B Forleo, MD, PhD, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT01501331     History of Changes
Other Study ID Numbers: PTVCARDIO2011_01
Study First Received: December 6, 2011
Last Updated: February 17, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University of Rome Tor Vergata:
Congestive Heart Failure
Cardiac Resynchronization Therapy
Internal Cardioverter Defibrillators

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014