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Completed

NCT Number: NCT03870074

CPET Predicts Long-term Survival and Positive Response to CRT

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Death

    Time frame: Follow up within 5 years from CRT

    All cause death, data from hospital entries and phone follow-up .

  2. Heart transplantation

    Time frame: Follow up within 5 years from CRT

    Heart transplantation as the definitive therapy of end-stage heart failure.

Secondary outcomes

  1. Positive response to CRT

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study title

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

Acronym: CPET-CRT

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2019
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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