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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014