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Completed

NCT Number: NCT04141345

Comorbid Chronic Lung Disease on Heart Failure

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.

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Key information

Conditions

Comorbid Chronic Lung Disease on Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2018
First posted
Oct 28, 2019
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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