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

NCT00700700 | Terminated Phase 4

• 1 other identifier: DMED-1082-07
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Cardiac Resynchronization Therapy; Dyspnea; Exercise Tolerance

Outcome Measures

Primary Outcomes (1)

• Exercise endurance time

  6 weeks

Study Arms (2)

CRT-ON/CRT-OFF

ACTIVE COMPARATOR

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

Device: Active Cardiac Resynchronization Therapy (CRT)

CRT-OFF/CRT-ON

ACTIVE COMPARATOR

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

Device: Active Cardiac Resynchronization Therapy (CRT)

Interventions

Active Cardiac Resynchronization Therapy (CRT) DEVICE

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

Also known as: Received one of the above devices used in 2007-2008 at Kingston General Hospital.

CRT-OFF/CRT-ON; CRT-ON/CRT-OFF

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris M. Parker, MD, MSc

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: June 19, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 6, 2011

Record last verified: 2011-07

Locations

CA (1)