Comorbid Chronic Lung Disease on Heart Failure

NCT04141345 | Completed

• 1 other identifier: 201701459B0
• Study Type: observational
• Target: 169
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Comorbid Chronic Lung Disease on Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

cardiopulmonary exercise test DIAGNOSTIC_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 with chronic lung disease; Heart failure without chronic lung disease

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Interventions

Exercise Test

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 Design

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

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: May 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2018
• Last Updated: October 28, 2019

Record last verified: 2019-10