HemodynamicsHemReXNCT01974557
The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans
A study testing Exercise in people with Hemodynamics, run by Finn Gustafsson at 1 site in Denmark.
Trial summary
Primary: To observe how hemodynamic parameters are affected by age during rest and exercise in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Exercise
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Jul 2015
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years
- No acute or chronic diseases that can influence hemodynamics
- Pause in medication with effect on hemodynamics 24h before experimental day
- Echocardiography, with no structural abnormalities with an impact on hemodynamics.
- ECG without any pathological findings, including arrhythmia
- Normal red and white blood count, normal renal, liver, thyroid, immune, and hematological function as well as normal electrolytes, HbA1c and natriuretic peptides
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- Ability to perform graded bicycle exercise testing
- BMI in the range of 20-30 kg/m2
- Height within population mean ±2 standard deviations
- VO2-max within population mean ±2 standard deviations (age corrected)
- Acceptable sonographic conditions
- Informed consent
Who cannot join
- History of heart failure (verified or suspected), or heart failure verified by pathological left and right systolic and diastolic measurements of the heart
- Hypotension (systolic blood pressure < 100 mmHg)
- Inability to participate
- Pregnant women
- Diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark
Copenhagen, 2100
About this study
Primary: To observe how hemodynamic parameters are affected by age during rest and exercise in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.
Secondary: To thoroughly examine this population with regard to cardiac performance and function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary status, and humoral markers of organ functions. This population will serve as a healthy control group, to which different populations can be compared, hence the need for a comprehensive characterization.
Read more
Hypotheses:
Diastolic function and parameters associated with diastolic function gradually deteriorate with increasing age. The gradual deterioration is unmasked at an earlier age during exercise and fluid challenge, compared to measurements made at rest.
- Conditions
- Hemodynamics
- Being tested
- Exercise
- Keywords
- Cardiac physiology, ageing, gender differences, diastole, fluid challenge
- Medical subject headings
- Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of hemodynamic parameters
Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.
Measured: minutes
Secondary outcomes (1)
Composite of humoral markers
Blood samples will be analysed with regard to humoral peptides and hormones that may affect hemodynamics.
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemodynamicsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finn Gustafsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, M.D. Msc, Principal investigator, Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974557
- Sponsor's protocol ID
- H-2-2013-072
- Acronym
- HemReX
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2013
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen MJ, Wolsk E, Bakkestrom R, Christensen N, Carter-Storch R, Omar M, Dahl JS, Frederiksen PH, Borlaug B, Gustafsson F, Hassager C, Moller JE. Pressure-flow responses to exercise in aortic stenosis, mitral regurgitation and diastolic dysfunction. Heart. 2022 Nov 10;108(23):1895-1903. doi: 10.1136/heartjnl-2022-321204.
PubMed 36356959Andersen MJ, Wolsk E, Bakkestrom R, Thomsen JH, Balling L, Dahl JS, Gustafsson F, Moller JE, Hassager C. Hemodynamic Response to Rapid Saline Infusion Compared with Exercise in Healthy Participants Aged 20-80 Years. J Card Fail. 2019 Nov;25(11):902-910. doi: 10.1016/j.cardfail.2019.06.004. Epub 2019 Jun 17.
PubMed 31220623
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans
- ClinicalTrials.gov ID
- NCT01974557
- Acronym / sponsor ID
- HemReX / H-2-2013-072
- Conditions
- Hemodynamics
- Keywords
- Cardiac physiology, ageing, gender differences, diastole, fluid challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Finn GustafssonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Nov 2013 (estimated)
- 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.
Primary: To observe how hemodynamic parameters are affected by age during rest and exercise in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.
Secondary: To thoroughly examine this population with regard to cardiac performance and function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary status, and humoral markers of organ functions. This population will serve as a healthy control group, to which different populations can be compared, hence the need for a comprehensive characterization.
Hypotheses:
Diastolic function and parameters associated with diastolic function gradually deteriorate with increasing age. The gradual deterioration is unmasked at an earlier age during exercise and fluid challenge, compared to measurements made at rest.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age over 18 years
- No acute or chronic diseases that can influence hemodynamics
- Pause in medication with effect on hemodynamics 24h before experimental day
- Echocardiography, with no structural abnormalities with an impact on hemodynamics.
- ECG without any pathological findings, including arrhythmia
Key exclusion criteria (5 listed)
- History of heart failure (verified or suspected), or heart failure verified by pathological left and right systolic and diastolic measurements of the heart
- Hypotension (systolic blood pressure < 100 mmHg)
- Inability to participate
- Pregnant women
- Diabetes
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 |
|---|---|---|
| Exercise | Other | – |
Primary outcome
Composite of hemodynamic parameters
Time frame: minutes
Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.
1 secondary outcome
Composite of humoral markers
Time frame: up to 1 hour
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 22 Oct 2015.
- Derived from this study: PubMed 36356959Andersen MJ, Wolsk E, Bakkestrom R, Christensen N, Carter-Storch R, Omar M, Dahl JS, Frederiksen PH, Borlaug B, Gustafsson F, Hassager C, Moller JE. Pressure-flow responses to exercise in aortic stenosis, mitral regurgitation and diastolic dysfunction. Heart. 2022 Nov 10;108(23):1895-1903. doi: 10.1136/heartjnl-2022-321204.
- Derived from this study: PubMed 31220623Andersen MJ, Wolsk E, Bakkestrom R, Thomsen JH, Balling L, Dahl JS, Gustafsson F, Moller JE, Hassager C. Hemodynamic Response to Rapid Saline Infusion Compared with Exercise in Healthy Participants Aged 20-80 Years. J Card Fail. 2019 Nov;25(11):902-910. doi: 10.1016/j.cardfail.2019.06.004. Epub 2019 Jun 17.
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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.
Finn Gustafsson, M.D. Msc principal investigator
Chief Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hemodynamics, run by Finn Gustafsson at 1 site in Denmark.
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 12 inclusion and 5 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 22 Oct 2015. 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 Denmark. 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?
Composite of hemodynamic parameters (time frame: minutes). 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 NCT01974557, which also lists 2 linked publications.
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 22 Oct 2015.