Optimized Peak VO2 in Predicting Advanced HF

Completed

• Conditions: Transplant; Failure, Heart; Morality; Heart Failure
• Interventions: Diagnostic Test: cardiopulmonary exercise test

• Registration Number: NCT05212649
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2014-05-01
• Primary Completion: 2020-06-30
• Study Completion: 2021-07-30
• Status Verified: 2021-12
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-16
• Study First Posted: 2022-01-28
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
More-GDMT	cardiopulmonary exercise test	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.
Few-GDMT group	cardiopulmonary exercise test	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital Heart Failure Center; 🇨🇳 Kaohsiung, Taiwan