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HaemoDYNAMICs in Primary and Secondary Hypertension

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01742702
Acronym
DYNAMIC
Enrollment
2000
Registered
2012-12-05
Start date
2006-05-25
Completion date
2025-12-31
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Primary Hypertension, Renal Insufficiency, Secondary Hypertension

Keywords

Blood pressure, Hypertension, Arterial stiffness, Cardiac output, Vascular resistance, Pulse wave reflection, Head-up tilt

Brief 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 cardiography in both supine position and during head-up tilt. For comparison, haemodynamics of subjects with chronic fatigue syndrome will also be recorded.

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).

Interventions

DIETARY_SUPPLEMENTLiquorice (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).

DRUGNitroglycerin 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).

DRUGSalbutamol 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).

DRUGL-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).

DIETARY_SUPPLEMENTSmall 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).

DRUGBisoprolol (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).

Sponsors

Finnish Foundation for Cardiovascular Research
CollaboratorOTHER
Paavo Nurmi Foundation
CollaboratorUNKNOWN
Sigrid Jusélius Foundation
CollaboratorOTHER
Finnish Cultural Foundation
CollaboratorOTHER
Tampere Tuberculosis Foundation
CollaboratorOTHER
Medical Research Fund of the Tampere University Hospital, Finland
CollaboratorOTHER
Aarne Koskelo Foundation
CollaboratorOTHER
Finnish Medical Foundation
CollaboratorNETWORK
Finnish Kidney Foundation
CollaboratorUNKNOWN
Päivikki and Sakari Sohlberg Foundation, Finland
CollaboratorOTHER
Tampere University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Pregnancy * Systolic blood pressure \<90 mmHg * Allergies to test compounds

Design outcomes

Primary

MeasureTime frameDescription
Change in haemodynamic variables during the follow-upbaseline, ten yearsHaemodynamic measurements are performed at baseline, and after approximately 10 years of follow-up
Cardiovascular eventsten years of follow-upAll cardiovascular events during follow-up

Secondary

MeasureTime frameDescription
Haemodynamic response to head-up tilt and research drugs0, 5, 10, 15, 20, 25 and 30 minutesRapid haemodynamic responses are assessed during the same measurement session (the response to head-up tilt and to research drugs salbutamol, nitroglycerin and L-arginine)
Haemodynamic response to bisoprolol or dietary supplements (liquorice, milk casein-derived polypeptides)baseline and after 2 weeks (liquorice); 3 weeks (bisoprolol), or 12 weeks (polypeptides)The change in haemodynamic variables after daily consumption of liquorice (2 weeks); bisoprolol (3 weeks); small milk casein-derived polypeptides (12 weeks)
Haemodynamic changes induced by Ironman competitionRecordings within 2 hours after completion Ironman competition, 12-18 hours later, and within 1-4 before or 4-8 weeks after the competitionRecordings are performed during normal conditions (training peroid) and after completion of a full-length Ironman competition

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026