Cardiovascular DiseasesNCT04929431
Validation of an Algorithm to Predict the Ventilatory Threshold
An observational study of Cardiovascular Diseases, run by Hasselt University at 1 site in Belgium.
Trial summary
The aim of the current study was to develop an algorithm which has the ability to accurately predict the first and second ventilatory threshold and in cardiovascular disease patients and to guide in proper exercise intensity determination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 3,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 1 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From April 2015 up to July 2020, data from CVD (risk) patients (e.g. obesity, diabetes, coronary artery disease or heart failure) were collected from Jessa hospital, Hasselt, Belgium, and Hasselt university, Faculty of Rehabilitation Sciences, Hasselt, Belgium, in light of research studies. All participants signed an informed consent (approved by the ethical committees of Jessa hospital Hasselt and/or Hasselt University) explaining the nature and risks of CPET, and allowing us to use anonymized data for the analyses of their CPET at entry of CR or an exercise intervention
Who may be able to join
- CVD patients (eg obesity, diabetes, coronary heart disease, heart failure)
Who cannot join
- No present CVD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of an Algorithm to Predict the Ventilatory Threshold for Exercise Intensity Prescription in Patients With Cardiovascular Disease
The aim of the current study was to develop an algorithm which has the ability to accurately predict the first and second ventilatory threshold and in cardiovascular disease patients and to guide in proper exercise intensity determination. This would then help, at least in part, to overcome the lack of access to metabolic carts or cardiopulmonary exercise test, and/or methodological difficulties with ventilatory threshold determination in these patients.
Read the detailed description
Design
This study is composed out of two sub studies: 1. Generation/creation of VT prediction algorithm, and 2. Validation of this algorithm in independent laboratories.
Sub study 1: Generation/creation of VT prediction algorithm
From April 2015 up to July 2020, data from CVD (risk) patients (e.g. obesity, diabetes, coronary artery disease or heart failure) were collected from in light of research studies. All participants signed an informed consent explaining the nature and risks of CPET, and allowing us to use anonymized data for the analyses of their CPET at entry of cardiovascular rehabilitation or an exercise intervention. These data have been published in previous publications.
Sub study 2: Validation of the algorithm in independent laboratories
From April 2015 up to July 2020, data from CVD (risk) patients (e.g. obesity, diabetes, coronary artery disease or heart failure) were collected in light of research studies. All participants signed an informed consent (approved by the ethics committees of the local hospitals or research laboratories) explaining the nature and risks of CPET, and allowing us to use anonymized data for the analyses of their CPET at entry of CR or an exercise intervention. These data have been published in previous publications
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration during cardiopulmonary exercise testing
Test duration (min)
Measured: Baseline - day 1
Workload during cardiopulmonary exercise testing
Peak workload (watt)
Measured: Baseline - day 1
Heart rate during cardiopulmonary exercise testing
Peak heart rate (bpm)
Measured: Baseline - day 1
Oxygen uptake during cardiopulmonary exercise testing
Maximal oxygen uptake (ml/kg/min)
Measured: Baseline - day 1
Heart rate in rest during cardiopulmonary exercise testing
Resting heart rate (bpm)
Measured: Baseline - day 1
Secondary outcomes (12)
Hypertension (in mmHg)
Blood pressure measurement with a automatic blood pressure cuff.
Measured: Baseline
Dyslipdemia (in mg/dl)
Blood lipid concentration in mg/dl
Measured: Baseline
Diabetes (mg/dl)
Glucose concentration in the blood in mg/dl
Measured: Baseline
Obesity
Presence of obesity determined by the BMI (see below)
Measured: Baseline
Smoking
Presence of smoking by questionnaire (yes/no)
Measured: Baseline
Medication intake
Information regarding medication intake will be retrospectively extracted by personal communication with the subject
Measured: Baseline
Cardiovascular surgery
Information regarding cardiovascular surgery will be extracted by personal communication with the subject
Measured: Baseline
Age in years
Age in years will be retrospectively extracted from the databank
Measured: Baseline
Gender (m/f)
Gender in m/f will be retrospectively extracted from the databank
Measured: Baseline
Length in meters
Length in meter will be retrospectively extracted from the databank
Measured: Baseline
Weight in kg
Weight in kg will be retrospectively extracted from the databank
Measured: Baseline
BMI (kg/m^2)
Weight (in kg) and height (in m) will be combined to assess BMI (in kg/m^2)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Mar 2021
- Primary completion30 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brasilia, University of Bern, Universitaire Ziekenhuizen KU Leuven, University of Siena, Technical University of Munich
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, Prof.dr, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929431
- Sponsor's protocol ID
- VT algorithm validation
- Status last verified
- Jun 2021
- First submitted
- 18 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Algorithm to Predict the Ventilatory Threshold for Exercise Intensity Prescription in Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04929431
- Acronym / sponsor ID
- VT algorithm validation
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- University of Brasilia, University of Bern, Universitaire Ziekenhuizen KU Leuven, University of Siena, Technical University of Munich
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 18 Jun 2021 (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.
The aim of the current study was to develop an algorithm which has the ability to accurately predict the first and second ventilatory threshold and in cardiovascular disease patients and to guide in proper exercise intensity determination. This would then help, at least in part, to overcome the lack of access to metabolic carts or cardiopulmonary exercise test, and/or methodological difficulties with ventilatory threshold determination in these patients.
Detailed description
Design
This study is composed out of two sub studies: 1. Generation/creation of VT prediction algorithm, and 2. Validation of this algorithm in independent laboratories.
Sub study 1: Generation/creation of VT prediction algorithm
From April 2015 up to July 2020, data from CVD (risk) patients (e.g. obesity, diabetes, coronary artery disease or heart failure) were collected from in light of research studies. All participants signed an informed consent explaining the nature and risks of CPET, and allowing us to use anonymized data for the analyses of their CPET at entry of cardiovascular rehabilitation or an exercise intervention. These data have been published in previous publications.
Sub study 2: Validation of the algorithm in independent laboratories
From April 2015 up to July 2020, data from CVD (risk) patients (e.g. obesity, diabetes, coronary artery disease or heart failure) were collected in light of research studies. All participants signed an informed consent (approved by the ethics committees of the local hospitals or research laboratories) explaining the nature and risks of CPET, and allowing us to use anonymized data for the analyses of their CPET at entry of CR or an exercise intervention. These data have been published in previous publications
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From April 2015 up to July 2020, data from CVD (risk) patients (e.g. obesity, diabetes, coronary artery disease or heart failure) were collected from Jessa hospital, Hasselt, Belgium, and Hasselt university, Faculty of Rehabilitation Sciences, Hasselt, Belgium, in light of research studies. All participants signed an informed consent (approved by the ethical committees of Jessa hospital Hasselt and/or Hasselt University) explaining the nature and risks of CPET, and allowing us to use anonymized data for the analyses of their CPET at entry of CR or an exercise intervention
Key inclusion criteria (1 listed)
- CVD patients (eg obesity, diabetes, coronary heart disease, heart failure)
Key exclusion criteria (1 listed)
- No present CVD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration during cardiopulmonary exercise testing
Time frame: Baseline - day 1
Test duration (min)
Workload during cardiopulmonary exercise testing
Time frame: Baseline - day 1
Peak workload (watt)
Heart rate during cardiopulmonary exercise testing
Time frame: Baseline - day 1
Peak heart rate (bpm)
Oxygen uptake during cardiopulmonary exercise testing
Time frame: Baseline - day 1
Maximal oxygen uptake (ml/kg/min)
Heart rate in rest during cardiopulmonary exercise testing
Time frame: Baseline - day 1
Resting heart rate (bpm)
12 secondary outcomes
Hypertension (in mmHg)
Time frame: Baseline
Dyslipdemia (in mg/dl)
Time frame: Baseline
Diabetes (mg/dl)
Time frame: Baseline
Obesity
Time frame: Baseline
Smoking
Time frame: Baseline
Medication intake
Time frame: Baseline
Cardiovascular surgery
Time frame: Baseline
Age in years
Time frame: Baseline
Gender (m/f)
Time frame: Baseline
Length in meters
Time frame: Baseline
Weight in kg
Time frame: Baseline
BMI (kg/m^2)
Time frame: Baseline
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 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Dominique Hansen, Prof.dr principal investigator
Hasselt 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 Cardiovascular Diseases, run by Hasselt University at 1 site in Belgium.
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 18 Jun 2021. 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 Belgium. 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?
Duration during cardiopulmonary exercise testing (time frame: Baseline - day 1). The study lists 5 primary outcomes in all. 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 18 Jun 2021.