CPET Predicts Long-term Survival and Positive Response to CRT

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03870074

Acronym

CPET-CRT

Enrollment

122

Registered

2019-03-11

Start date

2009-10-31

Completion date

2017-10-31

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

heart failure, cardiac resynchronization therapy, cardiopulmonary exercise test, responders to CRT, non-responders to CRT, survival prognosis after CRT

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Outcome results