Outcome, FatalNCT05189301
Oxygen Pulse and Its Curve Patterns in Male Patients With Heart Failure and Chronic Obstructive Pulmonary Disease With and in Healthy Men
An observational study of Outcome, Fatal, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Background: In non-invasive cardiopulmonary exercise testing (CPET), oxygen pulse (O2P) is defined as oxygen uptake divided by heart rate and is equal to the product of stroke volume and oxygen extraction by cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outcome, Fatal
- What is being tested?
- first pass study and cardiopulmonary exercise testing
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 27 May 2021
- 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 Any age
- Child, Adult, Older adult
Study population: COPD. Participants with COPD were referred by pulmonologists, and they all had respiratory symptoms, risk factors and a post-bronchodilator forced expired volume in one second (FEV1)/forced vital capacity (FVC) of <0.7 in accordance with the Global Initiative for Chronic Lung Disease criteria.[23] Participants with a significant post-bronchodilator effect (increase in FEV1 >12% and 200 mL from baseline) were excluded. HFrEF/HFmrEF. Participants with HFrEF/HFmrEF who had reduced and mildly reduced EFs were referred by cardiologists, and they were enrolled if they had New York Heart Association functional class (NYHA) I-III, and risk factors. A left ventricular EF using two-dimensional echocardiography (2DLVEF) <45-50% was obtained within 2 months before or after commencing the study.[24] Normal controls. Healthy subjects were recruited among the hospital staff and the local community through personal contacts. They were free of known significant diseases.
Who may be able to join
- Subjects aged from 40-85 years with the BMI of 18-28kg/m2 are to be enrolled: sample sizes of the norms, heart failure and COPD groups are 10, 20, and 20, respectively, equally distributed in two years. All of the participants had been in a stable clinical condition for at least 1 month before participating in the study. None of the participants had contraindications for cardiopulmonary exercise tests (CPETs).
Who cannot join
- Participants with diabetes mellitus, uncontrolled hypertension, arrhythmia, cancer, liver, renal or autoimmune diseases, or anemia were excluded. However, participants with well controlled diabetes mellitus were included in the HFrEF/HFmrEF group as these conditions often co-exist. Physical activity was not encouraged or limited during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Differences in Oxygen Pulse Pattern During Maximum Incremental Exercise Test Between Norms and Patients With Chronic Obstructive Pulmonary Disease and With Chronic Heart Failure - the Possible Mechanisms
Background: In non-invasive cardiopulmonary exercise testing (CPET), oxygen pulse (O2P) is defined as oxygen uptake divided by heart rate and is equal to the product of stroke volume and oxygen extraction by cells. As per, the O2P indicates the capability of oxygen consumption of whole body tissues and cells per heart beat. During exercise, the O2P changes can be deemed as the stroke volume changes as the oxygen extraction by muscle cells are normal. Hence, CPET-O2P can be non-invasively and continuously used to monitor the stroke volume changes during exercise. O2P value (i.e., % of predicted) is related to the severity and prognosis of heart failure and to the severity of constraint of the heart caused by exercise-induced hyperinflation or air trapping in patients with chronic obstructive pulmonary disease (COPD). However, O2P plateau pattern is not uncommonly encountered in the daily practice.
Hypothesis and aims: O2P patterns during incremental exercise are seldom investigated although they have been hypothesized that the plateau or decreasing patterns are related to myocardial failure or ischemia. In this proposal, the O2P patterns are to be thoroughly investigated: (1) the patterns in norms, patients with heart failure and COPD, (2) the relationship between the O2P pattern and cardiac function and/or myocardial ischemia in patients with heart failure and COPD. As yet there are no relative reports on the O2P pattern and its possible mechanisms in the literature, the results of the proposal might tremendously impact the interpretation strategy of CPET reports.
Methods: Multidisciplinary, prospective, comparative cross-sectional study is designed. Subjects aged from 40-85 years with the BMI of 18-28kg/m2 are to be enrolled: sample sizes of the norms, heart failure and COPD groups are 10, 20, and 20, respectively, equally distributed in two years. The definitions of COPD and heart failure with NYHA class I-III are according to the GOLD and ESC guidelines, respectively。All the three groups undergo CPET-NIRS, echocardiography, and the first pass and myocardial perfusion studies using Tc-99. The primary measurements are the O2P patterns and the cardiac function measured with echocardiography, the first pass and myocardial perfusion studies and air trapping in the lungs.。 Statistical analysis: For normal continuous data, t-test or ANOVA is used. For non-normal data, the Mann-Whitney test is used. The chi-square test or Fisher's exact test is used to compare the proportion of categorical variables between the two groups. A p value of less than .05 is considered to be statistically significant. Statistical procedures are performed using the SAS software package version 9.3.
- Conditions
- Outcome, Fatal
- Being tested
- first pass study, cardiopulmonary exercise testing
- Keywords
- exercise testing, oxygen pulse, chronic obstructive pulmonary disease, congestive heart failure, first pass study
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first pass studyDiagnostic test
Radionuclide assessment of ventricular performance was performed (Symbia T2, Germany)
cardiopulmonary exercise testingDiagnostic test
to measured (mL/min, STPD), CO2 output ( ) (mL/min), and minute ventilation ( ) (L/min, BTPS) breath by-breath (MasterScreen CPX™, Germany)
| Study group | Role | What they receive |
|---|---|---|
| CHF | CHF for chronic heart failure Receives: Diagnostic Test: first pass study; Diagnostic Test: cardiopulmonary exercise testing | |
| COPD | COPD for chronic obstructive pulmonary disease Receives: Diagnostic Test: first pass study; Diagnostic Test: cardiopulmonary exercise testing | |
| control | control for normal controls Receives: Diagnostic Test: first pass study; Diagnostic Test: cardiopulmonary exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
O2P and its patterns
O2P value and its pattern were measured by exercise gas exchange.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Outcome, FatalStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Lung Chuang, Chung Shan Medical University
- Investigators
- Ming-Lung Chuang, M.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189301
- Sponsor's protocol ID
- CSH-2019-C-030
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chuang ML, Tsai CF, Ueng KC, Weng JH, Tsai MF, Lo CH, Chen GB, Sia SK, Chuang YT, Wu TC, Kao PF, Hsieh MJ. The Impact of Oxygen Pulse and Its Curve Patterns on Male Patients with Heart Failure, Chronic Obstructive Pulmonary Disease, and Healthy Controls-Ejection Fractions, Related Factors and Outcomes. J Pers Med. 2022 Apr 28;12(5):703. doi: 10.3390/jpm12050703.
PubMed 35629127
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differences in Oxygen Pulse Pattern During Maximum Incremental Exercise Test Between Norms and Patients With Chronic Obstructive Pulmonary Disease and With Chronic Heart Failure - the Possible Mechanisms
- ClinicalTrials.gov ID
- NCT05189301
- Acronym / sponsor ID
- CSH-2019-C-030
- Conditions
- Outcome, Fatal
- Keywords
- exercise testing, oxygen pulse, chronic obstructive pulmonary disease, congestive heart failure, first pass study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 12 Jan 2022 (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.
Background: In non-invasive cardiopulmonary exercise testing (CPET), oxygen pulse (O2P) is defined as oxygen uptake divided by heart rate and is equal to the product of stroke volume and oxygen extraction by cells. As per, the O2P indicates the capability of oxygen consumption of whole body tissues and cells per heart beat. During exercise, the O2P changes can be deemed as the stroke volume changes as the oxygen extraction by muscle cells are normal. Hence, CPET-O2P can be non-invasively and continuously used to monitor the stroke volume changes during exercise. O2P value (i.e., % of predicted) is related to the severity and prognosis of heart failure and to the severity of constraint of the heart caused by exercise-induced hyperinflation or air trapping in patients with chronic obstructive pulmonary disease (COPD). However, O2P plateau pattern is not uncommonly encountered in the daily practice.
Hypothesis and aims: O2P patterns during incremental exercise are seldom investigated although they have been hypothesized that the plateau or decreasing patterns are related to myocardial failure or ischemia. In this proposal, the O2P patterns are to be thoroughly investigated: (1) the patterns in norms, patients with heart failure and COPD, (2) the relationship between the O2P pattern and cardiac function and/or myocardial ischemia in patients with heart failure and COPD. As yet there are no relative reports on the O2P pattern and its possible mechanisms in the literature, the results of the proposal might tremendously impact the interpretation strategy of CPET reports.
Methods: Multidisciplinary, prospective, comparative cross-sectional study is designed. Subjects aged from 40-85 years with the BMI of 18-28kg/m2 are to be enrolled: sample sizes of the norms, heart failure and COPD groups are 10, 20, and 20, respectively, equally distributed in two years. The definitions of COPD and heart failure with NYHA class I-III are according to the GOLD and ESC guidelines, respectively。All the three groups undergo CPET-NIRS, echocardiography, and the first pass and myocardial perfusion studies using Tc-99. The primary measurements are the O2P patterns and the cardiac function measured with echocardiography, the first pass and myocardial perfusion studies and air trapping in the lungs.。 Statistical analysis: For normal continuous data, t-test or ANOVA is used. For non-normal data, the Mann-Whitney test is used. The chi-square test or Fisher's exact test is used to compare the proportion of categorical variables between the two groups. A p value of less than .05 is considered to be statistically significant. Statistical procedures are performed using the SAS software package version 9.3.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF | – | Diagnostic Test: first pass study, Diagnostic Test: cardiopulmonary exercise testingCHF for chronic heart failure |
| COPD | – | Diagnostic Test: first pass study, Diagnostic Test: cardiopulmonary exercise testingCOPD for chronic obstructive pulmonary disease |
| control | – | Diagnostic Test: first pass study, Diagnostic Test: cardiopulmonary exercise testingcontrol for normal controls |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- COPD. Participants with COPD were referred by pulmonologists, and they all had respiratory symptoms, risk factors and a post-bronchodilator forced expired volume in one second (FEV1)/forced vital capacity (FVC) of <0.7 in accordance with the Global Initiative for Chronic Lung Disease criteria.[23] Participants with a significant post-bronchodilator effect (increase in FEV1 >12% and 200 mL from baseline) were excluded. HFrEF/HFmrEF. Participants with HFrEF/HFmrEF who had reduced and mildly reduced EFs were referred by cardiologists, and they were enrolled if they had New York Heart Association functional class (NYHA) I-III, and risk factors. A left ventricular EF using two-dimensional echocardiography (2DLVEF) <45-50% was obtained within 2 months before or after commencing the study.[24] Normal controls. Healthy subjects were recruited among the hospital staff and the local community through personal contacts. They were free of known significant diseases.
Key inclusion criteria (1 listed)
- Subjects aged from 40-85 years with the BMI of 18-28kg/m2 are to be enrolled: sample sizes of the norms, heart failure and COPD groups are 10, 20, and 20, respectively, equally distributed in two years. All of the participants had been in a stable clinical condition for at least 1 month before participating in the study. None of the participants had contraindications for cardiopulmonary exercise tests (CPETs).
Key exclusion criteria (1 listed)
- Participants with diabetes mellitus, uncontrolled hypertension, arrhythmia, cancer, liver, renal or autoimmune diseases, or anemia were excluded. However, participants with well controlled diabetes mellitus were included in the HFrEF/HFmrEF group as these conditions often co-exist. Physical activity was not encouraged or limited during the study period.
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 |
|---|---|---|
| first pass studyRadionuclide assessment of ventricular performance was performed (Symbia T2, Germany) | Diagnostic test | CHF, COPD, control |
| cardiopulmonary exercise testingto measured (mL/min, STPD), CO2 output ( ) (mL/min), and minute ventilation ( ) (L/min, BTPS) breath by-breath (MasterScreen CPX™, Germany) | Diagnostic test | CHF, COPD, control |
Primary outcome
O2P and its patterns
Time frame: one hour
O2P value and its pattern were measured by exercise gas exchange.
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 12 Jan 2022.
- Derived from this study: PubMed 35629127Chuang ML, Tsai CF, Ueng KC, Weng JH, Tsai MF, Lo CH, Chen GB, Sia SK, Chuang YT, Wu TC, Kao PF, Hsieh MJ. The Impact of Oxygen Pulse and Its Curve Patterns on Male Patients with Heart Failure, Chronic Obstructive Pulmonary Disease, and Healthy Controls-Ejection Fractions, Related Factors and Outcomes. J Pers Med. 2022 Apr 28;12(5):703. doi: 10.3390/jpm12050703.
- Individual participant dataSharing planned: No
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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.
Ming-Lung Chuang, M.D. principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome, Fatal, run by Chung Shan Medical University at 1 site in Taiwan.
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 1 inclusion and 1 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 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
O2P and its patterns (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05189301, which also lists 1 linked publication.
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 12 Jan 2022.