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

N

National Institute of Cardiology, Warsaw, Poland

Status

Completed

Conditions

Heart Failure With Reduced Ejection Fraction

Study type

Observational

Funder types

Other

Identifiers

NCT03870074
2.30/IV/09

Details and patient eligibility

About

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

Full 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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

122 participants in 2 patient groups

Responders
Description:
Patients with improvement of at least one NYHA class after one year from CRT.
Non-responders
Description:
Patients with no improvement of at least one NYHA class after one year from CRT.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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