Study Results
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Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2006-05-25
2025-12-31
Brief Summary
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Detailed Description
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Therefore, we investigated the haemodynamic changes in primary and secondary hypertension and in the control subjects with non-invasive radial pulse wave analysis and whole-body impedance cardiography. The method includes the determination of volume status using bioimpedance spectroscopy, determination of peripheral and central BP, cardiac function, vascular resistance, arterial compliance and indices of pulse wave reflection. Besides the measurements performed in the supine position, passive orthostatic challenge is included in the protocol to assess the upright functional haemodynamic status.
The repeatability and reproducibility of the protocol was first examined with a double-blind, randomized protocol in 35 subjects (methodological study group), and after that the administration of research drugs has been open-label. The effects of single doses of two largely endothelium-dependent agents, inhaled salbutamol and intravenous L-arginine, and one endothelium-independent agent, sublingual nitroglycerin, were investigated. However, challenges with the acute dosing of all medical compounds was terminated at the end of December 2016. Thereafter, the measurement protocol has included supine and upright recordings on the tilt-table, followed by supine measurements during paced breathing (15 breaths per minute for 5 minutes, 6 breaths per minute for 5 minutes) that modulate the autonomic nervous tone.
The study population has consisted of subgroups described below. The study protocol of each subgroup has been approved by the ethics committee of the Pirkanmaa Hospital District (Ethics committee ID's above), and the administration of research drugs has also been approved by the Finnish Agency for Medicines (EudraCT-numbers above).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DYNAMIC (ongoing)
Subjects with primary or secondary hypertension and normotensive control subjects. In addition haemodynamic recordings to 50 subjects suffering from chronic fatigue syndrome will be performed.
No interventions assigned to this group
AERO-DYNAMIC (recordings completed)
Subjects who had voluntarily decided to participate in a professionally coached marathon school (Varala Sports Institute, Tampere) were given the chance for haemodynamic recordings before, during and after the training protocol.
Nitroglycerin 0.25 mg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a single dose of sublingual nitroglycerin was given to examine the associated acute haemodynamic effects (recordings completed).
Salbutamol 400 µg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a 400 µg dose of inhaled salbutamol was given to examine the associated acute haemodynamic effects (recordings completed).
Liquorice (recordings completed)
Normotensive subjects, daily liquorice ingestion (daily glycyrrhizin dose 290-370 mg) for 2 weeks, haemodynamic measurements before and after the intervention.
Nitroglycerin 0.25 mg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a single dose of sublingual nitroglycerin was given to examine the associated acute haemodynamic effects (recordings completed).
Salbutamol 400 µg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a 400 µg dose of inhaled salbutamol was given to examine the associated acute haemodynamic effects (recordings completed).
Liquorice (2 weeks, glycyrrhizin 290-370 mg daily, no longer given since 2012)
Daily liquorice intake (daily glycyrrhizin dose 290-370 mg) for two weeks, measurements before and after intervention (recordings completed).
Milk polypeptides (recordings completed)
Daily ingestion of yoghurt containing small milk casein-derived polypeptides for 12 weeks versus placebo yoghurt.
Small milk casein-derived polypeptides (12 weeks daily, recordings completed 2011)
Daily intake of yoghurt containing small milk casein-derived polypeptides (12 weeks) and placebo yoghurt (12 weeks), measurements before and after intervention (recordings completed 2011).
Bisoprolol (recordings completed)
Hypertensive subjects, bisoprolol 5 mg once daily versus placebo in a double-blind, cross-over protocol.
Nitroglycerin 0.25 mg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a single dose of sublingual nitroglycerin was given to examine the associated acute haemodynamic effects (recordings completed).
Salbutamol 400 µg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a 400 µg dose of inhaled salbutamol was given to examine the associated acute haemodynamic effects (recordings completed).
Bisoprolol (5 mg daily for 3 weeks, recordings completed 2011)
Bisoprolol 5 mg daily for 3 weeks and placebo tablet daily for 3 weeks, double-blind, randomized, placebo-controlled cross-over protocol. Measurements before and after interventions (recordings completed 2011).
Aortic stenosis (ongoing)
Subjects with aortic stenosis confirmed by echocardiography
No interventions assigned to this group
Methodological (recordings completed)
35 normotensive subjects who received research drugs (nitroglycerin, salbutamol, placebo resoriblet, placebo inhalation, L-arginine infusion, saline infusion) in a placebo-controlled, double-blinded manner
Nitroglycerin 0.25 mg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a single dose of sublingual nitroglycerin was given to examine the associated acute haemodynamic effects (recordings completed).
Salbutamol 400 µg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a 400 µg dose of inhaled salbutamol was given to examine the associated acute haemodynamic effects (recordings completed).
L-arginine (10 min infusion, no longer given since January 2017)
From the beginning of the study until the end of year 2016 L-arginine infusion 10 mg/kg/min could be given for 10 minutes to examine acute haemodynamic effects (recordings completed).
Participants of Ironman Triathlon
Altogether 80 athletes participating in a full length Ironman competition. Non-invasive recordingds are performed under normal conditions during the training period and after completion of a full-length Ironman competition.
No interventions assigned to this group
Interventions
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Nitroglycerin 0.25 mg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a single dose of sublingual nitroglycerin was given to examine the associated acute haemodynamic effects (recordings completed).
Salbutamol 400 µg (single dose, no longer given since January 2017)
From the beginning of the study until the end of year 2016 a 400 µg dose of inhaled salbutamol was given to examine the associated acute haemodynamic effects (recordings completed).
L-arginine (10 min infusion, no longer given since January 2017)
From the beginning of the study until the end of year 2016 L-arginine infusion 10 mg/kg/min could be given for 10 minutes to examine acute haemodynamic effects (recordings completed).
Liquorice (2 weeks, glycyrrhizin 290-370 mg daily, no longer given since 2012)
Daily liquorice intake (daily glycyrrhizin dose 290-370 mg) for two weeks, measurements before and after intervention (recordings completed).
Small milk casein-derived polypeptides (12 weeks daily, recordings completed 2011)
Daily intake of yoghurt containing small milk casein-derived polypeptides (12 weeks) and placebo yoghurt (12 weeks), measurements before and after intervention (recordings completed 2011).
Bisoprolol (5 mg daily for 3 weeks, recordings completed 2011)
Bisoprolol 5 mg daily for 3 weeks and placebo tablet daily for 3 weeks, double-blind, randomized, placebo-controlled cross-over protocol. Measurements before and after interventions (recordings completed 2011).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hypertensive subjects (primary or secondary hypertension)
* Normotensive control subjects
* Subjects with aortic stenosis (subgroup "aortic stenosis")
* Participants of Ironman Triathlon competition
Exclusion Criteria
* Systolic blood pressure \<90 mmHg
* Allergies to test compounds
18 Years
99 Years
ALL
Yes
Sponsors
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Finnish Foundation for Cardiovascular Research
OTHER
Paavo Nurmi Foundation
UNKNOWN
Sigrid Jusélius Foundation
OTHER
Finnish Cultural Foundation
OTHER
Tampere Tuberculosis Foundation
OTHER
Medical Research Fund of the Tampere University Hospital, Finland
OTHER
Aarne Koskelo Foundation
OTHER
Finnish Medical Foundation
NETWORK
Finnish Kidney Foundation
UNKNOWN
Päivikki and Sakari Sohlberg Foundation, Finland
OTHER
Tampere University
OTHER
Responsible Party
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Ilkka Pörsti, MD
MD, PhD, Professor of Internal Medicine
Principal Investigators
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Ilkka Pörsti, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tampere University
Locations
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Tampere University
Tampere, Southern Finland, Finland
Tampere University Hospital
Tampere, Southern Finland, Finland
Countries
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Facility Contacts
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References
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Taurio J, Hautaniemi EJ, Koskela JK, Eraranta A, Hamalainen M, Tikkakoski A, Kettunen JA, Kahonen M, Niemela O, Moilanen E, Mustonen J, Porsti I. The characteristics of elevated blood pressure in abdominal obesity correspond to primary hypertension: a cross-sectional study. BMC Cardiovasc Disord. 2023 Mar 27;23(1):161. doi: 10.1186/s12872-023-03150-w.
Koskela JK, Tahvanainen A, Tikkakoski AJ, Kangas P, Uitto M, Viik J, Kahonen M, Mustonen J, Porsti I. Resting heart rate predicts cardiac autonomic modulation during passive head-up tilt in subjects without cardiovascular diseases. Scand Cardiovasc J. 2022 Dec;56(1):138-147. doi: 10.1080/14017431.2022.2079713.
Hamid H, Kurra V, Choudhary MK, Bouquin H, Niemela O, Kahonen MAP, Mustonen JT, Porsti IH, Koskela JK. Plasma uric acid is related to large arterial stiffness but not to other hemodynamic variables: a study in 606 normotensive and never-medicated hypertensive subjects. BMC Cardiovasc Disord. 2021 May 26;21(1):257. doi: 10.1186/s12872-021-02072-9.
Kokko E, Nevalainen PI, Choudhary MK, Koskela J, Tikkakoski A, Huhtala H, Niemela O, Viukari M, Mustonen J, Matikainen N, Porsti I. Aldosterone-to-renin ratio is related to arterial stiffness when the screening criteria of primary aldosteronism are not met. Sci Rep. 2020 Nov 13;10(1):19804. doi: 10.1038/s41598-020-76718-7.
Hautaniemi EJ, Tikkakoski AJ, Eraranta A, Kahonen M, Hamalainen E, Turpeinen U, Huhtala H, Mustonen J, Porsti IH. Liquorice ingestion attenuates vasodilatation via exogenous nitric oxide donor but not via beta2-adrenoceptor stimulation. PLoS One. 2019 Oct 18;14(10):e0223654. doi: 10.1371/journal.pone.0223654. eCollection 2019.
Kangas P, Tahvanainen A, Tikkakoski A, Koskela J, Uitto M, Viik J, Kahonen M, Koobi T, Mustonen J, Porsti I. Increased Cardiac Workload in the Upright Posture in Men: Noninvasive Hemodynamics in Men Versus Women. J Am Heart Assoc. 2016 Jun 21;5(6):e002883. doi: 10.1161/JAHA.115.002883.
Wilenius M, Tikkakoski AJ, Tahvanainen AM, Haring A, Koskela J, Huhtala H, Kahonen M, Koobi T, Mustonen JT, Porsti IH. Central wave reflection is associated with peripheral arterial resistance in addition to arterial stiffness in subjects without antihypertensive medication. BMC Cardiovasc Disord. 2016 Jun 7;16:131. doi: 10.1186/s12872-016-0303-6.
Tahvanainen AM, Tikkakoski AJ, Koskela JK, Nordhausen K, Viitala JM, Leskinen MH, Kahonen MA, Koobi T, Uitto MT, Viik J, Mustonen JT, Porsti IH. The type of the functional cardiovascular response to upright posture is associated with arterial stiffness: a cross-sectional study in 470 volunteers. BMC Cardiovasc Disord. 2016 May 23;16:101. doi: 10.1186/s12872-016-0281-8.
Leskinen MH, Hautaniemi EJ, Tahvanainen AM, Koskela JK, Paallysaho M, Tikkakoski AJ, Kahonen M, Koobi T, Niemela O, Mustonen J, Porsti IH. Daily liquorice consumption for two weeks increases augmentation index and central systolic and diastolic blood pressure. PLoS One. 2014 Aug 25;9(8):e105607. doi: 10.1371/journal.pone.0105607. eCollection 2014.
Koskela JK, Tahvanainen A, Haring A, Tikkakoski AJ, Ilveskoski E, Viitala J, Leskinen MH, Lehtimaki T, Kahonen MA, Koobi T, Niemela O, Mustonen JT, Porsti IH. Association of resting heart rate with cardiovascular function: a cross-sectional study in 522 Finnish subjects. BMC Cardiovasc Disord. 2013 Nov 15;13:102. doi: 10.1186/1471-2261-13-102.
Other Identifiers
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2006-002065-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2009-014542-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R07110M
Identifier Type: OTHER
Identifier Source: secondary_id
R07053M
Identifier Type: OTHER
Identifier Source: secondary_id
R08012
Identifier Type: OTHER
Identifier Source: secondary_id
R09103M
Identifier Type: OTHER
Identifier Source: secondary_id
R10056
Identifier Type: OTHER
Identifier Source: secondary_id
R06086M
Identifier Type: OTHER
Identifier Source: secondary_id
R21094
Identifier Type: OTHER
Identifier Source: secondary_id
R06086M
Identifier Type: -
Identifier Source: org_study_id
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