NCT01974557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

October 22, 2013

Last Update Submit

October 20, 2015

Conditions

Hemodynamics

Keywords

Cardiac physiologyageinggender differencesdiastolefluid challenge

Outcome Measures

Primary Outcomes (1)

  • Composite of hemodynamic parameters

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

    minutes

Secondary Outcomes (1)

  • Composite of humoral markers

    up to 1 hour

Interventions

ExerciseOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 36356959DERIVED

  • 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.

    PMID: 31220623DERIVED

MeSH Terms

Conditions

Heart Murmurs

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Finn Gustafsson, M.D. Msc

    Chief Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

October 22, 2013

First Posted

November 1, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

DK(1)