CClinicalTrials.gg
CompletedNCT05212649Updated Aug 30, 2023

Optimized Peak VO2 in Predicting Advanced HF

An observational study in Heart Failure, Morality and Transplant; Failure, Heart, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
377
Ages
20 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Heart Failure
  • Morality
  • Transplant; Failure, Heart

Browse trials for

Keywords

  • advance heart failure
  • cardiac transplantation
  • Peak oxygen consumption
  • Guideline-directed medical therapy
  • Risk score
  • Heart Failure Survival Score
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 377 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
377 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Diagnostic Test: cardiopulmonary exercise test

Interventions

  • Diagnostic testcardiopulmonary exercise 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.

06

What researchers measure

Primary outcomes

  1. all-cause mortality

    Number of participants that had occurrence of the mortality which is defined as all-cause mortality

    Time frame: May, 2014 ~ June 2020

  2. urgent heart transplant

    Number of participants that had occurrence of the urgent heart transplant

    Time frame: May, 2014 ~ June 2020

07

Study locations

1 site
  • Chang Gung Memorial Hospital Heart Failure Center
    Kaohsiung, 83341, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided — Individual participant data sharing plans will be discussed with other investigators

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05212649
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jan 28, 2022
Start date
May 1, 2014
Primary completion
Jun 30, 2020
Completion
Jul 30, 2021
Last update
Aug 30, 2023

Study contacts

Shyh-Ming Chen, MD
principal investigator · Chang Gung Medical Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion