Comorbid Chronic Lung Disease on Heart FailureNCT04141345
Comorbid Chronic Lung Disease on Heart Failure
An observational study of Comorbid Chronic Lung Disease on Heart Failure, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbid Chronic Lung Disease on Heart Failure
- What is being tested?
- cardiopulmonary exercise test
- How many people
- 169 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cannot tolerance exercise test due to muscular-skeletal disorder
- Cannot co-operate all functional studies
- Family reject to participate in this project
About this study
Official title: 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.
Read the 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.
- Being tested
- cardiopulmonary exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary exercise testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: May, 2007 ~ January, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study startMay 2007
- Primary completionJul 2010
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comorbid Chronic Lung Disease on Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141345
- Sponsor's protocol ID
- 201701459B0
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will discuss with other investigators about individual participant data (IPD) sharing.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Comorbid Chronic Lung Disease on Heart Failure Long-Term Outcomes: Relevance of Ventilatory Inefficiency
- ClinicalTrials.gov ID
- NCT04141345
- Acronym / sponsor ID
- 201701459B0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2007 (actual)
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure with chronic lung disease | – | Diagnostic Test: cardiopulmonary exercise testPatients 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 | – | Diagnostic Test: cardiopulmonary exercise testPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Cannot tolerance exercise test due to muscular-skeletal disorder
- Cannot co-operate all functional studies
- Family reject to participate in this project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary exercise testPatients 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. | Diagnostic test | Heart failure with chronic lung disease, Heart failure without chronic lung disease |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: Undecided. We will discuss with other investigators about individual participant data (IPD) sharing.
Related trials for Comorbid Chronic Lung Disease on Heart Failure
Enrolling by invitationObservational study
The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease
COPD, COPD Exacerbation Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Comorbid Chronic Lung Disease on Heart Failure, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.