Heart FailureNCT05212649
Optimized Peak VO2 in Predicting Advanced HF
An observational study of Heart Failure and Morality, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The ability and timely selection of severe heart failure (HF) patients for cardiac transplantation and advanced HF therapy is challenging. Peak VO2 by cardiopulmonary exercise test (CPET) was used for transplant listing. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Heart Failure, Morality, Transplant; Failure, Heart
- What is being tested?
- cardiopulmonary exercise test
- How many people
- 377 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2014to 30 Jul 2021
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators retrospectively collected acute HF patients discharged alive from the hospital. Investigators divided participants into more-GDMT (>= 2 kinds) and few-GDMT (<2 kinds) groups and compared the prognostic significance of peak VO2 and Heart Failure Survival Score for combined all-cause mortality and urgent cardiac transplantation.
Who may be able to join
- acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF <=40%) and discharged alive from the hospital
- patients with age >= 20 years of age
- patients who performed cardiopulmonary exercise test (CPET) within one month after discharge
- patients with serum B-type natriuretic peptide (BNP) level >100 pg/mL.
Who cannot join
- patients with estimated survival time < 6 months
- patients who could not tolerate exercise test due to muscular-skeletal disorder or other reason
- patients who had severe valvular heart disease.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital Heart Failure Center
Kaohsiung City, 83341
About this study
Official title: Optimizing Risk Stratification in Predicting Poor Prognosis in Post-Acute Heart Failure With Reduced Ejection Fraction
The ability and timely selection of severe heart failure (HF) patients for cardiac transplantation and advanced HF therapy is challenging. Peak VO2 by cardiopulmonary exercise test (CPET) was used for transplant listing. This study aimed to reassess the prognostic significance of peak VO2 and to compare that with the Heart Failure Survival Score in the current optimized novel guideline-directed medical therapy (GDMT).
Read the detailed description
Investigators retrospectively collected acute HF patients discharged alive from the hospital. Investigators divided participants into more-GDMT (≥2 kinds) and few-GDMT (<2 kinds) groups and compared the prognostic significance of peak VO2 and HFSS for combined all-cause mortality and urgent cardiac transplantation.
- Conditions
- Heart Failure, Morality, Transplant; Failure, Heart
- Being tested
- cardiopulmonary exercise test
- Keywords
- advance heart failure, cardiac transplantation, Peak oxygen consumption, Guideline-directed medical therapy, Risk score, Heart Failure Survival Score
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary exercise testDiagnostic test
CPET was performed in this HF cohort within one month after being discharged and interpreted as previously described. Patients underwent an upright graded cycle ergometer exercise using a personalized ramp protocol or a motorized treadmill using a modified Bruce or Cornell protocol. Peak VO2 data measured by cycle ergometer were increased by 10% to allow a comparison between the two different procedures. Peak VO2 was defined as the highest 30-second average value obtained during exercise. Submaximal CPET variables such as ventilatory efficiency were calculated by the slope of VE versus VCO2 below the ventilatory compensatory point (VCP). If the slope of VE/VCO2 can't be calculated, we used the nadir of VE/VCO2, or the ratio of VE/VCO2 at the anaerobic threshold (AT) as the variable of ventilatory efficiency. The AT was determined by the V-slope method.
| Study group | Role | What they receive |
|---|---|---|
| More-GDMT | Baseline guideline-directed medications therapy (GDMT), including angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blocker (ARB), beta-blockers, mineralocorticoid receptor antagonist (MRA), and angiotensin receptor neprilysin inhibitor (ARNI) were documented at discharge. More-GDMT group was defined as patient population received GDMT >=2 kinds of above medications. Receives: Diagnostic Test: cardiopulmonary exercise test | |
| Few-GDMT group | Baseline guideline-directed medications therapy (GDMT), including angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blocker (ARB), beta-blockers, mineralocorticoid receptor antagonist (MRA), and angiotensin receptor neprilysin inhibitor (ARNI) were documented at discharge. Few GDMT-group was defined as patients who received GDMT < 2 kinds of the above medications. Receives: Diagnostic Test: cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Number of participants that had occurrence of the mortality which is defined as all-cause mortality
Measured: May, 2014 ~ June 2020
urgent heart transplant
Number of participants that had occurrence of the urgent heart transplant
Measured: May, 2014 ~ June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 May 2014
- Primary completion30 Jun 2020
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Retrospective
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyh-Ming Chen, MD, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212649
- Sponsor's protocol ID
- 202001285B0D001
- Status last verified
- Dec 2021
- First submitted
- 3 Jan 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing plans will be discussed with other investigators
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Risk Stratification in Predicting Poor Prognosis in Post-Acute Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT05212649
- Acronym / sponsor ID
- 202001285B0D001
- Conditions
- Heart Failure, Morality, Transplant; Failure, Heart
- Keywords
- advance heart failure, cardiac transplantation, Peak oxygen consumption, Guideline-directed medical therapy, Risk score, Heart Failure Survival Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 28 Jan 2022 (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 ability and timely selection of severe heart failure (HF) patients for cardiac transplantation and advanced HF therapy is challenging. Peak VO2 by cardiopulmonary exercise test (CPET) was used for transplant listing. This study aimed to reassess the prognostic significance of peak VO2 and to compare that with the Heart Failure Survival Score in the current optimized novel guideline-directed medical therapy (GDMT).
Detailed description
Investigators retrospectively collected acute HF patients discharged alive from the hospital. Investigators divided participants into more-GDMT (≥2 kinds) and few-GDMT (<2 kinds) groups and compared the prognostic significance of peak VO2 and HFSS for combined all-cause mortality and urgent cardiac transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| More-GDMT | – | Diagnostic Test: cardiopulmonary exercise testBaseline guideline-directed medications therapy (GDMT), including angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blocker (ARB), beta-blockers, mineralocorticoid receptor antagonist (MRA), and angiotensin receptor neprilysin inhibitor (ARNI) were documented at discharge. More-GDMT group was defined as patient population received GDMT >=2 kinds of above medications. |
| Few-GDMT group | – | Diagnostic Test: cardiopulmonary exercise testBaseline guideline-directed medications therapy (GDMT), including angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blocker (ARB), beta-blockers, mineralocorticoid receptor antagonist (MRA), and angiotensin receptor neprilysin inhibitor (ARNI) were documented at discharge. Few GDMT-group was defined as patients who received GDMT < 2 kinds of the above medications. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators retrospectively collected acute HF patients discharged alive from the hospital. Investigators divided participants into more-GDMT (>= 2 kinds) and few-GDMT (<2 kinds) groups and compared the prognostic significance of peak VO2 and Heart Failure Survival Score for combined all-cause mortality and urgent cardiac transplantation.
Key inclusion criteria (4 listed)
- acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF <=40%) and discharged alive from the hospital
- patients with age >= 20 years of age
- patients who performed cardiopulmonary exercise test (CPET) within one month after discharge
- patients with serum B-type natriuretic peptide (BNP) level >100 pg/mL.
Key exclusion criteria (3 listed)
- patients with estimated survival time < 6 months
- patients who could not tolerate exercise test due to muscular-skeletal disorder or other reason
- patients who had severe valvular heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary exercise testCPET was performed in this HF cohort within one month after being discharged and interpreted as previously described. Patients underwent an upright graded cycle ergometer exercise using a personalized ramp protocol or a motorized treadmill using a modified Bruce or Cornell protocol. Peak VO2 data measured by cycle ergometer were increased by 10% to allow a comparison between the two different procedures. Peak VO2 was defined as the highest 30-second average value obtained during exercise. Submaximal CPET variables such as ventilatory efficiency were calculated by the slope of VE versus VCO2 below the ventilatory compensatory point (VCP). If the slope of VE/VCO2 can't be calculated, we used the nadir of VE/VCO2, or the ratio of VE/VCO2 at the anaerobic threshold (AT) as the variable of ventilatory efficiency. The AT was determined by the V-slope method. | Diagnostic test | Few-GDMT group, More-GDMT |
Primary outcome
all-cause mortality
Time frame: May, 2014 ~ June 2020
Number of participants that had occurrence of the mortality which is defined as all-cause mortality
urgent heart transplant
Time frame: May, 2014 ~ June 2020
Number of participants that had occurrence of the urgent heart transplant
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 30 Aug 2023.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing plans will be discussed with other investigators
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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.
Shyh-Ming Chen, MD principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Morality, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
all-cause mortality (time frame: May, 2014 ~ June 2020). 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 30 Aug 2023.