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

This study has been completed.
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: November 16, 2014
Last verified: November 2014

December 6, 2011
November 16, 2014
December 2011
November 2014   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01501331 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Congestive Heart Failure
Device: CRTD or ICD (Energen)
RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators
RRT diagnostic tool
Patients implanted with an Energen device or successor.
Intervention: Device: CRTD or ICD (Energen)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01501331
PTVCARDIO2011_01
No
Giovanni B Forleo, University of Rome Tor Vergata
University of Rome Tor Vergata
Not Provided
Principal Investigator: Giovanni B Forleo, MD, PhD University of Rome Tor Vergata
Principal Investigator: Luca Santini, MD, PhD University of Rome Tor Vergata
University of Rome Tor Vergata
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP