Comorbid Chronic Lung Disease on Heart Failure

Completed

• Conditions: Comorbid Chronic Lung Disease on Heart Failure
• Interventions: Diagnostic Test: cardiopulmonary exercise test

• Registration Number: NCT04141345
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2007-05
• Primary Completion: 2010-07
• Study Completion: 2018-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Last Update Submitted: 2019-10-24
• Study First Posted: 2019-10-28
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure with chronic lung disease	cardiopulmonary exercise test	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.
Heart failure without chronic lung disease	cardiopulmonary exercise test	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.

Primary Outcome Measures

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