Optimized Peak VO2 in Predicting Advanced HF

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Morality Transplant; Failure, Heart

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital Heart Failure Center

Kaohsiung City, 83341, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiopulmonary exercise test

Diagnostic 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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2021
First posted: Jan 28, 2022
Registry last updated: Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed