Heart Failure With Reduced Ejection FractionCPET-CRTNCT03870074
CPET Predicts Long-term Survival and Positive Response to CRT
An observational study of Heart Failure With Reduced Ejection Fraction, run by National Institute of Cardiology, Warsaw, Poland.
Trial summary
The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- severe chronic obstructive pulmonary disease (FEV1 <30%)
- inability to perform a stress test on a treadmill
About this study
Official title: Cardiopulmonary Exercise Test Predicts Long-term Survival and Positive Response to Cardiac Resynchronization Therapy.
The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT.
Read the 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.
- Keywords
- heart failure, cardiac resynchronization therapy, cardiopulmonary exercise test, responders to CRT, non-responders to CRT, survival prognosis after CRT
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All cause death, data from hospital entries and phone follow-up .
Measured: Follow up within 5 years from CRT
Heart transplantation
Heart transplantation as the definitive therapy of end-stage heart failure.
Measured: Follow up within 5 years from CRT
Secondary outcomes (1)
Positive response to CRT
Positive response to CRT was defined as the improvement in heart failure symptoms of 1 or more NYHA classes
Measured: Follow up within 1 year from CRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study startOct 2009
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Chwyczko, MD,PhD, Principal investigator, Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870074
- Sponsor's protocol ID
- 2.30/IV/09
- Acronym
- CPET-CRT
- Status last verified
- Mar 2019
- First submitted
- 21 Feb 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Test Predicts Long-term Survival and Positive Response to Cardiac Resynchronization Therapy.
- ClinicalTrials.gov ID
- NCT03870074
- Acronym / sponsor ID
- CPET-CRT / 2.30/IV/09
- Keywords
- heart failure, cardiac resynchronization therapy, cardiopulmonary exercise test, responders to CRT, non-responders to CRT, survival prognosis after CRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- severe chronic obstructive pulmonary disease (FEV1 <30%)
- inability to perform a stress test on a treadmill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: Follow up within 5 years from CRT
All cause death, data from hospital entries and phone follow-up .
Heart transplantation
Time frame: Follow up within 5 years from CRT
Heart transplantation as the definitive therapy of end-stage heart failure.
1 secondary outcome
Positive response to CRT
Time frame: Follow up within 1 year from CRT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Chwyczko, MD,PhD principal investigator
Institute of Cardiology
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by National Institute of Cardiology, Warsaw, Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Follow up within 5 years from CRT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.