CPET Predicts Long-term Survival and Positive Response to CRT

Heart Failure With Reduced Ejection Fraction Clinical Trial

— CPET-CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870074
• Other study ID #: 2.30/IV/09
• Status: Completed
• Start date: October 2009
• Est. completion date: October 2017

Study information

• Verified date: March 2019
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Outcome

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