CPET Predicts Long-term Survival and Positive Response to CRT (CPET-CRT)

Cardiopulmonary Exercise Test Predicts Long-term Survival and Positive Response to Cardiac Resynchronization Therapy.

The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Reduced Ejection Fraction

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 Type: Observational
• Enrollment (Actual): 122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study comprised 122 patients qualified for CRT-D and followed-up for five years after CRT implantation. Patients were qualified for CRT-D based on the guidelines of the European Society of Cardiology in 2007 and its update in 2010.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Responders; Patients with improvement of at least one NYHA class after one year from CRT.
Non-responders; Patients with no improvement of at least one NYHA class after one year from CRT.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland
• Investigators: Principal Investigator: Tomasz Chwyczko, MD,PhD, Institute of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; heart failure; cardiopulmonary exercise test; responders to CRT; non-responders to CRT; survival prognosis after CRT
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2.30/IV/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No