Optimized Peak VO2 in Predicting Advanced HF

NCT ID: NCT05212649

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 377 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2021-07-30

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.

Conditions

Heart Failure; Morality; Transplant; Failure, Heart

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

cardiopulmonary exercise test

Intervention Type: 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.

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.

cardiopulmonary exercise test

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shyh-Ming Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Foundation

Locations

Chang Gung Memorial Hospital Heart Failure Center

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

202001285B0D001

Identifier Type: -

Identifier Source: org_study_id