Oxygen Pulse and Its Curve Patterns in Male Patients With Heart Failure and Chronic Obstructive Pulmonary Disease With and in Healthy Men

Outcome, Fatal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05189301
• Other study ID #: CSH-2019-C-030
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: May 27, 2021

Study information

• Verified date: December 2021
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 27, 2021
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Outcome, Fatal
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• first pass study
Radionuclide assessment of ventricular performance was performed (Symbia T2, Germany)
• cardiopulmonary exercise testing
to measured (mL/min, STPD), CO2 output ( ) (mL/min), and minute ventilation ( ) (L/min, BTPS) breath by-breath (MasterScreen CPX™, Germany)

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	O2P and its patterns	O2P value and its pattern were measured by exercise gas exchange.	one hour