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

This study has been terminated.
(Stopped due to an inability to recruit eligible subjects.)
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00700700
First received: May 16, 2008
Last updated: July 4, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Device: Active Cardiac Resynchronization Therapy (CRT)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Exercise endurance time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Received one of the above devices used in 2007-2008 at Kingston General Hospital.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700700

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Chris M. Parker, MD, MSc Queen's University
  More Information

No publications provided

Responsible Party: Dr. Chris M. Parker, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier: NCT00700700     History of Changes
Other Study ID Numbers: DMED-1082-07
Study First Received: May 16, 2008
Last Updated: July 4, 2011
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Congestive Heart Failure
Cardiac Resynchronization Therapy
Dyspnea
Exercise Tolerance

Additional relevant MeSH terms:
Heart Failure
Dyspnea
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014