Comorbid Chronic Lung Disease on Heart Failure

Influence of Comorbid Chronic Lung Disease on Heart Failure Long-Term Outcomes: Relevance of Ventilatory Inefficiency

Comorbid chronic lung disease (CLD) increases mortality in heart failure (HF) patients. Understanding the predictors and pathophysiology of HF can improve the efficacy of HF treatment. This study evaluated the cardiopulmonary exercise test (CPET) results to identify significant predictors on long-term outcomes in HF patients with CLD.

Study Overview

• Status: Completed
• Conditions: Comorbid Chronic Lung Disease on Heart Failure
• Intervention / Treatment: Diagnostic test: cardiopulmonary exercise test

Detailed Description

The CPET was administered in a cohort of 169 HF outpatients with exercise intolerance at a tertiary referral center between May 2007 and July 2010. A CLD was defined as abnormal spirometry accompanied by clinical symptoms and signs included in the Global Initiative for Chronic Obstructive Lung Disease criteria. The primary endpoint was defined as CV mortality or the first HF hospitalization. Totally 49 events occurred before the end of follow up in January 2018.

• Study Type: Observational
• Enrollment (Actual): 169

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A cohort of 169 HF outpatients with exercise intolerance took the CPET at a tertiary referral center between May 2007 and July 2010. Patients were recruited consecutively based on clinical assessment of risk factors for HF and echocardiographic evidence of systolic dysfunction or diastolic dysfunction. In patients with normal LVEF (>=50), the diagnosis of diastolic dysfunction was based on echocardiographic parameters. Chronic lung disease (CLD) was defined as spirometry with obstructive lung disease or restrictive lung disease with accompanying clinical symptoms and signs included in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.

Description

Inclusion Criteria:

• outpatients ≥ 18 years of age, male or female.
• Patients with a diagnosis of heart failure with clinical symptoms and echocardiography evidence
• Patients received cardiopulmonary exercise test exams

Exclusion Criteria:

• Cannot tolerance exercise test due to muscular-skeletal disorder
• Cannot co-operate all functional studies
• Family reject to participate in this project

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart failure with chronic lung disease; Patients were recruited consecutively based on clinical assessment of risk factors for HF and echocardiographic evidence of systolic dysfunction or diastolic dysfunction. Risk factors for HF were defined as hypertension, atherosclerotic disease, obesity, chronic obstructive lung disease, metabolic syndrome, smoking, and family history of HF. In patients with normal LVEF (<50), diagnosis of diastolic dysfunction was based on echocardiographic parameters. Chronic lung disease (CLD) was defined as spirometry with obstructive lung disease or restrictive lung disease with accompanying clinical symptoms and signs included in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.	Diagnostic test: cardiopulmonary exercise test; Patients performed an upright graded bicycle exercise using a personalized protocol or performed a motorized treadmill exercise using a modified Bruce protocol. Peak VO2 and peak respiratory exchange ratio (RER) were defined as the highest 30-second average value obtained during exercise. The anaerobic threshold (AT) was determined by V-slope method. The VE(minute ventilation)/VCO2 (carbon dioxide production) at AT was calculated as the average VE/VCO2 for 1 minute during AT and immediately after AT. If AT could not be determined, the lowest VE/VCO2 was determined by averaging the three lowest consecutive 0.5-minute data points.
Heart failure without chronic lung disease; Patients were recruited consecutively based on clinical assessment of risk factors for HF and echocardiographic evidence of systolic dysfunction or diastolic dysfunction. Risk factors for HF were defined as hypertension, atherosclerotic disease, obesity, chronic obstructive lung disease, metabolic syndrome, smoking, and family history of HF. In patients with normal LVEF (<50), diagnosis of diastolic dysfunction was based on echocardiographic parameters. Chronic lung disease (CLD) was defined as spirometry with obstructive lung disease or restrictive lung disease with accompanying clinical symptoms and signs included in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. HF patients who did not have chronic lung disease were assigned as a non-CLD group.	Diagnostic test: cardiopulmonary exercise test; Patients performed an upright graded bicycle exercise using a personalized protocol or performed a motorized treadmill exercise using a modified Bruce protocol. Peak VO2 and peak respiratory exchange ratio (RER) were defined as the highest 30-second average value obtained during exercise. The anaerobic threshold (AT) was determined by V-slope method. The VE(minute ventilation)/VCO2 (carbon dioxide production) at AT was calculated as the average VE/VCO2 for 1 minute during AT and immediately after AT. If AT could not be determined, the lowest VE/VCO2 was determined by averaging the three lowest consecutive 0.5-minute data points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Had Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or First Heart Failure (HF) Hospitalization	Number of participants that had occurrence of the composite endpoint, which is defined as either CV death or first HF hospitalization	May, 2007 ~ January, 2018

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Heart Failure; Lung Diseases
• Other Study ID Numbers: 201701459B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will discuss with other investigators about individual participant data (IPD) sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No