Optimized Peak VO2 in Predicting Advanced HF

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212649
• Other study ID #: 202001285B0D001
• Status: Completed
• Start date: May 1, 2014
• Est. completion date: July 30, 2021

Study information

• Verified date: December 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Morality
• Transplant; Failure, Heart

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital Heart Failure Center	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	Number of participants that had occurrence of the mortality which is defined as all-cause mortality	May, 2014 ~ June 2020
Primary	urgent heart transplant	Number of participants that had occurrence of the urgent heart transplant	May, 2014 ~ June 2020