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Completed

NCT Number: NCT01501331

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

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRTD or ICD (Energen)

Device

RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

Multiparametric Evaluation of Heart Failure in Device-implanted Patients.

Acronym: MULTITUDE-HF

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 29, 2011
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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