The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans (HemReX)
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|ClinicalTrials.gov Identifier: NCT01974557|
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : October 22, 2015
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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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemodynamics||Other: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
- Composite of hemodynamic parameters [ Time Frame: minutes ]Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.
- Composite of humoral markers [ Time Frame: up to 1 hour ]Blood samples will be analysed with regard to humoral peptides and hormones that may affect hemodynamics.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974557
|Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Finn Gustafsson, M.D. Msc||Chief Physician|
|Responsible Party:||Finn Gustafsson, Chief Physician, Rigshospitalet, Denmark|
|Other Study ID Numbers:||
|First Posted:||November 1, 2013 Key Record Dates|
|Last Update Posted:||October 22, 2015|
|Last Verified:||October 2015|