Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients (CORRELATE-HF)

November 4, 2009 updated by: Boston Scientific Corporation

CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients

The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of the CORRELATE-HF study is to collect RRT data in heart failure patients to gain a better understanding of how respiratory rate changes in relation to all cause clinical events as well as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • UZ Brussel
  • United States
    • California
      • San Diego, California, United States, 91213
        • San Diego Cardiac Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients with an implanted CRT-D.

Description

Inclusion Criteria:

  • Implanted COGNIS device or future commercially available Boston Scientific CRT-D, that contains the Sensor Trend for Respiratory Rate, with a right ventricular lead and left ventricular lead actively implanted
  • Respiratory Sensor programmed "On"
  • Classified as having NYHA Class III heart failure documented, in the past 12 months
  • Age 18 or above, or of legal age to give informed consent specific to state and national law
  • Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol

Exclusion Criteria:

  • Inability or refusal to sign the patient Informed Consent
  • Inability or refusal to comply with the follow-up schedule
  • Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
  • Patients prescribed to positive airway pressure therapy
  • A life expectancy of less than 180 days, per physician discretion
  • Enrolled in any concurrent study without prior written approval from Boston Scientific CRM
  • Women who are pregnant or plan to become pregnant in the next twelve months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observation
Heart failure patients with an implanted CRT-D
Device: Cardiac Resynchronization Therapy Defibrillator
CRT-D observational study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Brian Jaski, MD, San Diego Cardiac Center
  • Principal Investigator: Pedro Brugada, MD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2009

Last Update Submitted That Met QC Criteria

November 4, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-CA-091008-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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