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Optimized Peak VO2 in Predicting Advanced HF

Optimizing Risk Stratification in Predicting Poor Prognosis in Post-Acute Heart Failure With Reduced Ejection Fraction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05212649
Enrollment
377
Registered
2022-01-28
Start date
2014-05-01
Completion date
2021-07-30
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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).

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.

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
all-cause mortalityMay, 2014 ~ June 2020Number of participants that had occurrence of the mortality which is defined as all-cause mortality
urgent heart transplantMay, 2014 ~ June 2020Number of participants that had occurrence of the urgent heart transplant

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026