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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00700700
• Other study ID #: DMED-1082-07
• Status: Terminated
• Phase: Phase 4
• First received: May 16, 2008
• Last updated: July 4, 2011
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Active Cardiac Resynchronization Therapy (CRT)
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

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise endurance time		6 weeks	No