Optimized Peak VO2 in Predicting Advanced HF

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05212649

Collaborator

(none)

377

Enrollment

Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Morality Transplant; Failure, Heart	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 Design

Study Type:

Observational

Actual Enrollment :

377 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

all-cause mortality [May, 2014 ~ June 2020]
Number of participants that had occurrence of the mortality which is defined as all-cause mortality
urgent heart transplant [May, 2014 ~ June 2020]
Number of participants that had occurrence of the urgent heart transplant

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.