Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF)

July 4, 2011 updated by: Queen's University

Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure

A new therapy for patients with advanced heart failure (HF) involves the implantation of a specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to restore the synchronized contraction of the ventricular chambers of the heart. In some people, CRT improves exertional breathlessness and allows them to exercise for longer periods. However, to date, the mechanisms by which CRT improves symptoms and exercise tolerance is unknown. This study will use in-depth cardiopulmonary exercise testing and pulmonary function testing to explore these mechanisms in greater detail.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

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

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Kingston General Hospital

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 to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinically stable
  • being considered for implantation of biventricular pacemaker for CRT
  • LVEF <35%
  • QRS duration >120 msec
  • NYHA III-IV functional class
  • optimized pharmacologic management of CHF
  • no recent (<1 month) episodes of decompensated CHF

Exclusion Criteria:

  • inability to perform cycle ergometry or comply with testing
  • uncontrolled ischemic heart disease
  • coronary revascularization within 3 months of study entry
  • concurrent primary lung disease
  • current use of ambulatory oxygen
  • rhythm other than sinus
  • dependency on pacemaker therapy as a consequence of bradyarrhythmias
  • severe valvulopathy

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CRT-ON/CRT-OFF
Group initially randomized to CRT-ON, then cross-over to CRT-OFF
Device: Active Cardiac Resynchronization Therapy (CRT)

Initiation of active biventricular pacing/cardiac resynchronization therapy

Devices by Medtronic:

  1. Insync Sentry 7298 & 7299
  2. Concerto C174 ASK (Most frequently implanted)
  3. Insync III 8042 (PM)

Devices by Guidant/Boston Scientific:

  1. Contak Renewal 4 H190 & H199
  2. Contak Renewal 3 H127

Devices by ELA/Sorin:

1. Ovatio CRT 6750

Other Names:
  • Received one of the above devices used in 2007-2008 at Kingston General Hospital.
ACTIVE_COMPARATOR: CRT-OFF/CRT-ON
Group initially randomized to CRT-OFF, then cross-over to CRT-ON
Device: Active Cardiac Resynchronization Therapy (CRT)

Initiation of active biventricular pacing/cardiac resynchronization therapy

Devices by Medtronic:

  1. Insync Sentry 7298 & 7299
  2. Concerto C174 ASK (Most frequently implanted)
  3. Insync III 8042 (PM)

Devices by Guidant/Boston Scientific:

  1. Contak Renewal 4 H190 & H199
  2. Contak Renewal 3 H127

Devices by ELA/Sorin:

1. Ovatio CRT 6750

Other Names:
  • Received one of the above devices used in 2007-2008 at Kingston General Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise endurance time
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Queen's University

Investigators

  • Principal Investigator: Chris M. Parker, MD, MSc, Queen's University

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

October 1, 2008

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (ESTIMATE)

June 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 4, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMED-1082-07

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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