CPET Predicts Long-term Survival and Positive Response to CRT

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction

• Registration Number: NCT03870074
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Study First Submitted: 2019-02-21
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Study First Posted: 2019-03-11
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	Follow up within 5 years from CRT	All cause death, data from hospital entries and phone follow-up .
Heart transplantation	Follow up within 5 years from CRT	Heart transplantation as the definitive therapy of end-stage heart failure.

Secondary Outcome Measures

Name	Time	Method
Positive response to CRT	Follow up within 1 year from CRT	Positive response to CRT was defined as the improvement in heart failure symptoms of 1 or more NYHA classes