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

NCT ID: NCT01974557

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-07-31

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.

Conditions

Hemodynamics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Exercise

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Finn Gustafsson

OTHER

Sponsor Role: lead

Responsible Party

Finn Gustafsson

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Finn Gustafsson, M.D. Msc

Role: PRINCIPAL_INVESTIGATOR

Chief Physician

Locations

Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 36356959 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31220623 (View on PubMed)

Other Identifiers

H-2-2013-072

Identifier Type: -

Identifier Source: org_study_id