CPET Predicts Long-term Survival and Positive Response to CRT

NCT03870074 | Completed

• 1 other identifier: 2.30/IV/09
• Study Type: observational
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• Death

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

  Follow up within 5 years from CRT

• Heart transplantation

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

  Follow up within 5 years from CRT

Secondary Outcomes (1)

• Positive response to CRT

  Follow up within 1 year from CRT

Study Arms (2)

Responders

Patients with improvement of at least one NYHA class after one year from CRT.

Non-responders

Patients with no improvement of at least one NYHA class after one year from CRT.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study comprised 122 patients qualified for CRT-D and followed-up for five years after CRT implantation. Patients were qualified for CRT-D based on the guidelines of the European Society of Cardiology in 2007 and its update in 2010.

You may qualify if:

• 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.

You may not qualify if:

• severe chronic obstructive pulmonary disease (FEV1 \<30%)
• inability to perform a stress test on a treadmill

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tomasz Chwyczko, MD,PhD

  Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 11, 2019
• Study Start: October 1, 2009
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share