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Primary HypertensionDYNAMICNCT01742702

HaemoDYNAMICs in Primary and Secondary Hypertension

An observational study of Primary Hypertension and Secondary Hypertension, run by Tampere University at 2 sites in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary aim of the present study was to examine the haemodynamic changes in primary hypertension and secondary hypertension (renal diseases, endocrine diseases, obesity-associated hypertension) with a non-invasive haemodynamic measurement protocol utilizing radial pulse wave analysis and whole-body impedance… Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
What is being tested?
Nitroglycerin 0.25 mg (single dose, no longer given since January 2017), Salbutamol 400 µg (single dose, no longer given since January 2017) and L-arginine (10 min infusion, no longer given since January 2017)
How many people
2,000 participants
Where
2 sitesFinland
Study dates
25 May 2006to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult hypertensive and normotensive subjects who were treated in Tampere University Hospital clinics of internal medicine or cardiology, or visited medical doctors as outpatients at occupational health care providers in the Pirkanmaa Hospital District. Patients with primary aldosteronism from all University clinics (Helsinki, Turku, Kuopio, Oulu) in Finland, who were referred to Tampere University Hospital for adrenal vein sampling. Patients with acromegalia from all University clinics (Helsinki, Turku, Kuopio, Oulu) in Finland. Participants of Ironman Triathlon competition.

Who may be able to join

  • Independent, community-dwelling adults
  • Hypertensive subjects (primary or secondary hypertension)
  • Normotensive control subjects
  • Subjects with aortic stenosis (subgroup "aortic stenosis")
  • Participants of Ironman Triathlon competition

Who cannot join

  • Pregnancy
  • Systolic blood pressure <90 mmHg
  • Allergies to test compounds

Trial locations and contacts

2 sites in 1 country.

Finland2 sites, 2 recruiting

  • Tampere University

    Tampere, Southern Finland, 33014

    Ilkka H Pörsti, MD, PhD, Professor, +358 40 5486507, ilkka.porsti@tuni.fi

    Elina J Hautaniemi, PhD, elina.hautaniemi@tuni.fi

    Recruiting

  • Tampere University Hospital

    Tampere, Southern Finland, 33521

    Ilkka H Pörsti, Professor, ilkka.porsti@tuni.fi

    Elina J Hautaniemi, PhD, elina.hautaniemi@tuni.fi

    Recruiting

Other trials in Finland

About this study

Official title: Non-Invasive HaemoDYNAMICs in Primary and Secondary Hypertension: the DYNAMIC-study

The primary aim of the present study was to examine the haemodynamic changes in primary hypertension and secondary hypertension (renal diseases, endocrine diseases, obesity-associated hypertension) with a non-invasive haemodynamic measurement protocol utilizing radial pulse wave analysis and whole-body impedance cardiography in both supine position and during head-up tilt. For comparison, haemodynamics of subjects with chronic fatigue syndrome will also be recorded.

Read the detailed description

Elevated blood pressure (BP) and related cardiovascular complications are the leading causes of morbidity and mortality in the modern world. In routine clinical practice, the haemodynamic status is commonly assessed by measuring heart rate and blood pressure at rest, which provides only limited information about functional haemodynamic status. In addition, the haemodynamic changes resulting in similar elevations of BP may differ substantially between patients and disorders.

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).

Being tested
Nitroglycerin 0.25 mg (single dose, no longer given since January 2017), Salbutamol 400 µg (single dose, no longer given since January 2017), L-arginine (10 min infusion, no longer given since January 2017), Liquorice (2 weeks, glycyrrhizin 290-370 mg daily, no longer given since 2012), Small milk casein-derived polypeptides (12 weeks daily, recordings completed 2011)
Keywords
Blood pressure, Hypertension, Arterial stiffness, Cardiac output, Vascular resistance, Pulse wave reflection, Head-up tilt
Medical subject headings
Essential Hypertension, Aortic Valve Stenosis, Renal Insufficiency, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitroglycerin 0.25 mg (single dose, no longer given since January 2017)Drug

    Also called Nitro resoriblet, Orion Pharma, Espoo, Finland

    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)Drug

    Also called Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK

    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)Drug

    Also called L-arginine HCl 20 mg ml/l, B. Braun Ag, Melsungen, Germany

    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)Dietary supplement

    Also called Halva liquorice (TM), Kouvola liquorice (TM)

    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)Dietary supplement

    Also called Valio (TM) evolus yoghurt

    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)Drug

    Also called Emconcor 5 mg, Merck KGaA, Darmstadt, Germany

    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).

Study groups in NCT01742702
Study groupRoleWhat they receive
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.
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.
Receives: Drug: Nitroglycerin 0.25 mg (single dose, no longer given since January 2017); Drug: Salbutamol 400 µg (single dose, no longer given since January 2017)
Liquorice (recordings completed)Normotensive subjects, daily liquorice ingestion (daily glycyrrhizin dose 290-370 mg) for 2 weeks, haemodynamic measurements before and after the intervention.
Receives: Drug: Nitroglycerin 0.25 mg (single dose, no longer given since January 2017); Drug: Salbutamol 400 µg (single dose, no longer given since January 2017); Dietary Supplement: Liquorice (2 weeks, glycyrrhizin 290-370 mg daily, no longer given since 2012)
Milk polypeptides (recordings completed)Daily ingestion of yoghurt containing small milk casein-derived polypeptides for 12 weeks versus placebo yoghurt.
Receives: Dietary Supplement: Small milk casein-derived polypeptides (12 weeks daily, recordings completed 2011)
Bisoprolol (recordings completed)Hypertensive subjects, bisoprolol 5 mg once daily versus placebo in a double-blind, cross-over protocol.
Receives: Drug: Nitroglycerin 0.25 mg (single dose, no longer given since January 2017); Drug: Salbutamol 400 µg (single dose, no longer given since January 2017); Drug: Bisoprolol (5 mg daily for 3 weeks, recordings completed 2011)
Aortic stenosis (ongoing)Subjects with aortic stenosis confirmed by echocardiography
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
Receives: Drug: Nitroglycerin 0.25 mg (single dose, no longer given since January 2017); Drug: Salbutamol 400 µg (single dose, no longer given since January 2017); Drug: L-arginine (10 min infusion, no longer given since January 2017)
Participants of Ironman TriathlonAltogether 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in haemodynamic variables during the follow-up

    Haemodynamic measurements are performed at baseline, and after approximately 10 years of follow-up

    Measured: baseline, ten years

  2. Cardiovascular events

    All cardiovascular events during follow-up

    Measured: ten years of follow-up

Secondary outcomes (3)

  1. Haemodynamic response to head-up tilt and research drugs

    Rapid haemodynamic responses are assessed during the same measurement session (the response to head-up tilt and to research drugs salbutamol, nitroglycerin and L-arginine)

    Measured: 0, 5, 10, 15, 20, 25 and 30 minutes

  2. Haemodynamic response to bisoprolol or dietary supplements (liquorice, milk casein-derived polypeptides)

    The change in haemodynamic variables after daily consumption of liquorice (2 weeks); bisoprolol (3 weeks); small milk casein-derived polypeptides (12 weeks)

    Measured: baseline and after 2 weeks (liquorice); 3 weeks (bisoprolol), or 12 weeks (polypeptides)

  3. Haemodynamic changes induced by Ironman competition

    Recordings are performed during normal conditions (training peroid) and after completion of a full-length Ironman competition

    Measured: Recordings within 2 hours after completion Ironman competition, 12-18 hours later, and within 1-4 before or 4-8 weeks after the competition

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2012 (estimated)
  2. Study start25 May 2006
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01742702
Sponsor's protocol ID
R06086M
Other IDs
2006-002065-39, 2009-014542-29, R07110M, R07053M, R08012, R09103M, R10056, R06086M
Acronym
DYNAMIC
Status last verified
Aug 2021
First submitted
29 Nov 2012
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36973671

  • 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.

    PubMed 35652524

  • 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.

    PubMed 34039285

  • 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.

    PubMed 33188272

  • 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.

    PubMed 31626649

  • 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.

    PubMed 27329447

  • 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.

    PubMed 27266507

  • 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.

    PubMed 27216309

  • 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.

    PubMed 25153328

  • 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.

    PubMed 24237764

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Hypertension and Secondary Hypertension, run by Tampere University at 2 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in haemodynamic variables during the follow-up (time frame: baseline, ten years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01742702, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

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