Cardiopulmonary Exercise Test Predicts Long-term Survival and Positive Response to Cardiac Resynchronization Therapy.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
- Enrollment
- 122
- Primary Endpoint
- Death
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT.
Detailed Description
Cardiac resynchronization therapy (CRT) is an acknowledged therapy of selected patients with heart failure (HF). One of the unresolved problems is high percentage of non-responders to CRT, reaching 40%. No single parameter, helpful in identifying non-responders prior to CRT implantation, was found. The study included patients with HF of ischemic or non-ischemic etiology, in NYHA class II-IV, EF≤35% and QRS≥120ms. All the patients had CRT implanted. Clinical evaluation, CPET and NT-proBNP levels measurement were performed before CRT implantation and after 3-6 months. Improvement in HF symptoms of one or more NYHA class correlated with two-years survival. It was used as the criterion of positive response to CRT.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HF in class III or IV according to New York Heart Association (NYHA) in the course of ischemic (ICM) or non-ischemic cardiomyopathy (NICM), QRS complex duration ≥ 120ms, EF ≤35% and dilatation of the left ventricle diastolic diameter \>55mm (LVdD), according to the ESC guidelines in 2007
- •HF in NYHA class II, LBBB with QRS complex duration ≥ 150 ms according to the guidelines update in 2010
- •optimal pharmacotherapy of HF in the period of three months prior to the study entry.
- •the expected survival of the patient \> 1 year.
Exclusion Criteria
- •severe chronic obstructive pulmonary disease (FEV1 \<30%)
- •inability to perform a stress test on a treadmill
Outcomes
Primary Outcomes
Death
Time Frame: Follow up within 5 years from CRT
All cause death, data from hospital entries and phone follow-up .
Heart transplantation
Time Frame: Follow up within 5 years from CRT
Heart transplantation as the definitive therapy of end-stage heart failure.
Secondary Outcomes
- Positive response to CRT(Follow up within 1 year from CRT)