The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans (HemReX)

• ClinicalTrials.gov Identifier: NCT01974557
• Recruitment Status: Completed
• First Posted: November 1, 2013
• Last Update Posted: October 22, 2015
• Sponsor: Finn Gustafsson
• Information provided by (Responsible Party): Finn Gustafsson, Rigshospitalet, Denmark

Tracking Information

• First Submitted Date: October 22, 2013
• First Posted Date: November 1, 2013
• Last Update Posted Date: October 22, 2015
• Study Start Date: October 2013
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2013)

Composite of hemodynamic parameters [ Time Frame: minutes ]

Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 27, 2013)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans
• Official Title: The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans

Brief 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Hemodynamics
• Intervention: Other: Exercise
• Study Arms: Not Provided

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.
• Andersen 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 27, 2013): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01974557
• Other Study ID Numbers: H-2-2013-072
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Finn Gustafsson, Rigshospitalet, Denmark
• Original Responsible Party: Same as current
• Current Study Sponsor: Finn Gustafsson
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Finn Gustafsson, M.D. Msc; Chief Physician

• PRS Account: Rigshospitalet, Denmark
• Verification Date: October 2015