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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501331
First Posted: December 29, 2011
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giovanni B Forleo, University of Rome Tor Vergata
  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 Giovanni B Forleo, 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 ]

    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 ]

    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 ]

    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 ]

    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
Study Completion Date: November 2014
Primary Completion Date: November 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

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 6, 2011
First Posted: December 29, 2011
Last Update Posted: November 18, 2014
Last Verified: November 2014

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases