Comorbid Chronic Lung Disease on Heart Failure

Comorbid Chronic Lung Disease on Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141345
• Other study ID #: 201701459B0
• Status: Completed
• Start date: May 2007
• Est. completion date: January 2018

Study information

• Verified date: October 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: January 2018
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comorbid Chronic Lung Disease on Heart Failure
• Heart Failure
• Lung Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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