Optimized Peak VO2 in Predicting Advanced HF

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Transplant; Failure, Heart; Morality
• Intervention / Treatment: Diagnostic test: cardiopulmonary exercise test

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 Type: Observational
• Enrollment (Actual): 377

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	Number of participants that had occurrence of the mortality which is defined as all-cause mortality	May, 2014 ~ June 2020
urgent heart transplant	Number of participants that had occurrence of the urgent heart transplant	May, 2014 ~ June 2020

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Shyh-Ming Chen, MD, Chang Gung Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Risk score; advance heart failure; cardiac transplantation; Peak oxygen consumption; Guideline-directed medical therapy; Heart Failure Survival Score
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 202001285B0D001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data sharing plans will be discussed with other investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No