Optimized Peak VO2 in Predicting Advanced HF

NCT05212649 | Completed

• 1 other identifier: 202001285B0D001
• Study Type: observational
• Target: 377
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure; Morality; Transplant; Failure, Heart

Keywords

advance heart failure; cardiac transplantation; Peak oxygen consumption; Guideline-directed medical therapy; Risk score; Heart Failure Survival Score

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

cardiopulmonary exercise test 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; More-GDMT

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital Heart Failure Center

Kaohsiung City, 83341, Taiwan

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Shyh-Ming Chen, MD

  Chang Gung Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 28, 2022
• Study Start: May 1, 2014
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2021
• Last Updated: August 30, 2023

Record last verified: 2021-12

Locations

TW (1)