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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03870074
Other study ID # 2.30/IV/09
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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