Cardiac FunctionSVprojectNCT04287114
Cardiac Stroke Volume at Rest and During Different Exercise Intensities
A study testing Acute exercise in people with Cardiac Function, run by Turku University Hospital at 2 sites in Finland.
Trial summary
The main aim of the present investigation is to study cardiac function in different exercise intensities in healthy human subjects. Two techniques will be used: cardiac ultrasound-derived stroke volume measurements and body impedance measurements. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Function
- What is being tested?
- Acute exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFinland
- Study dates
- 8 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45
- BMI 18-30
- Resting Blood pressure < 140/90 mmHg
- Participation in regular exercise
Who cannot join
- Acute illness
- Pregnancy
- Pace maker
- Artificial joint
- History of a cardiac event
- Insulin or medically treated diabetes
Show all 12Show fewer
- Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
- Abundant use of alcohol
- Use of narcotics
- Smoking of tobacco or consuming snuff tobacco
- Diagnosed depressive or bipolar disorder
- Abnormalities in resting ECG (revised by the study physician)
Trial locations and contacts
2 sites in 1 country.
Finland2 sites, 2 recruiting
- Recruiting
Turku PET Centre
Turku, 20521
Ilkka H Heinonen, PhD, +35823138145, ilkka.heinonen@utu.fi
Ilkka Heinonen, PhD
- Recruiting
University of Turku
Turku
Ilkka Heinonen, PhD
About this study
The main aim of the present investigation is to study cardiac function in different exercise intensities in healthy human subjects. Two techniques will be used: cardiac ultrasound-derived stroke volume measurements and body impedance measurements. 20 healthy men (n=10) and women (n=10) aged 18-45 years will be investigated at rest and during exercise. All study procedures are non-invasive.
- Conditions
- Cardiac Function
- Being tested
- Acute exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute exerciseBehavioural
Acute exercise with different exercise intensities
| Study group | Role | What they receive |
|---|---|---|
| Healthy young men and women | Experimental | Single group consisting of 10 men and 10 women Receives: Behavioral: Acute exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac stroke volume
Measured: 1 min
Secondary outcomes (2)
End-diastolic and end-systolic volumes
Measured: 1 min
Ejection fraction
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start8 Feb 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FunctionStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287114
- Sponsor's protocol ID
- T24/2020
- Acronym
- SVproject
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Stroke Volume at Rest and During Different Exercise Intensities
- ClinicalTrials.gov ID
- NCT04287114
- Acronym / sponsor ID
- SVproject / T24/2020
- Conditions
- Cardiac Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Feb 2020 (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 main aim of the present investigation is to study cardiac function in different exercise intensities in healthy human subjects. Two techniques will be used: cardiac ultrasound-derived stroke volume measurements and body impedance measurements. 20 healthy men (n=10) and women (n=10) aged 18-45 years will be investigated at rest and during exercise. All study procedures are non-invasive.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy young men and women | Experimental | Behavioral: Acute exerciseSingle group consisting of 10 men and 10 women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-45
- BMI 18-30
- Resting Blood pressure < 140/90 mmHg
- Participation in regular exercise
Key exclusion criteria (12 listed)
- Acute illness
- Pregnancy
- Pace maker
- Artificial joint
- History of a cardiac event
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 |
|---|---|---|
| Acute exerciseAcute exercise with different exercise intensities | Behavioural | Healthy young men and women |
Primary outcome
Cardiac stroke volume
Time frame: 1 min
2 secondary outcomes
End-diastolic and end-systolic volumes
Time frame: 1 min
Ejection fraction
Time frame: 1 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute exercise in people with Cardiac Function, run by Turku University Hospital at 2 sites in Finland.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilkka HA Heinonen, PhD (408393962 ext. +358, ilkka.heinonen@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac stroke volume (time frame: 1 min). 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 9 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.