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

Primary Purpose

Congestive Heart Failure

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Active Cardiac Resynchronization Therapy (CRT)
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Cardiac Resynchronization Therapy, Dyspnea, Exercise Tolerance

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CRT-ON/CRT-OFF

CRT-OFF/CRT-ON

Arm Description

Group initially randomized to CRT-ON, then cross-over to CRT-OFF

Group initially randomized to CRT-OFF, then cross-over to CRT-ON

Outcomes

Primary Outcome Measures

Exercise endurance time

Secondary Outcome Measures

Full Information

First Posted
May 16, 2008
Last Updated
July 4, 2011
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00700700
Brief Title
Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF)
Official Title
Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to an inability to recruit eligible subjects.
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive Heart Failure, Cardiac Resynchronization Therapy, Dyspnea, Exercise Tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-ON/CRT-OFF
Arm Type
Active Comparator
Arm Description
Group initially randomized to CRT-ON, then cross-over to CRT-OFF
Arm Title
CRT-OFF/CRT-ON
Arm Type
Active Comparator
Arm Description
Group initially randomized to CRT-OFF, then cross-over to CRT-ON
Intervention Type
Device
Intervention Name(s)
Active Cardiac Resynchronization Therapy (CRT)
Other Intervention Name(s)
Received one of the above devices used in 2007-2008 at Kingston General Hospital.
Intervention Description
Initiation of active biventricular pacing/cardiac resynchronization therapy Devices by Medtronic: Insync Sentry 7298 & 7299 Concerto C174 ASK (Most frequently implanted) Insync III 8042 (PM) Devices by Guidant/Boston Scientific: Contak Renewal 4 H190 & H199 Contak Renewal 3 H127 Devices by ELA/Sorin: 1. Ovatio CRT 6750
Primary Outcome Measure Information:
Title
Exercise endurance time
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris M. Parker, MD, MSc
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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