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

This study is currently recruiting participants.

Verified March 2013 by University of Rome Tor Vergata

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: March 7, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 6, 2011

Last Updated Date

March 7, 2013

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01501331 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Multiparametric Evaluation of Heart Failure in Device-implanted Patients.

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Device: CRTD or ICD (Energen)

RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators

Study Group/Cohort (s)

RRT diagnostic tool

Patients implanted with an Energen device or successor.

Intervention: Device: CRTD or ICD (Energen)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: GIOVANNI B FORLEO, MD, PHD	+39 0620904009	FORLEO@ME.COM
Contact: Luca Santini, MD		lsantini@alice.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01501331

Other Study ID Numbers ^ICMJE

PTVCARDIO2011_01

Has Data Monitoring Committee

Responsible Party

Giovanni B Forleo, University of Rome Tor Vergata

Study Sponsor ^ICMJE

University of Rome Tor Vergata

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Giovanni B Forleo, MD, PhD	University of Rome Tor Vergata
Principal Investigator:	Luca Santini, MD, PhD	University of Rome Tor Vergata

Information Provided By

University of Rome Tor Vergata

Verification Date

March 2013

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

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