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HaemoDYNAMICs in Primary and Secondary Hypertension (DYNAMIC)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Ilkka Porsti, University of Tampere
Sponsor:
Collaborators:
Finnish Foundation for Cardiovascular Research
Paavo Nurmi Foundation
Sigrid Jusélius Foundation
Finnish Cultural Foundation
Tampere Tuberculosis Foundation
Medical Research Fund of the Tampere University Hospital, Finland
Aarne Koskelo Foundation
Finnish Medical Foundation
Finnish Kidney Foundation
Päivikki and Sakari Sohlberg Foundation, Finland
Information provided by (Responsible Party):
Ilkka Porsti, University of Tampere
ClinicalTrials.gov Identifier:
NCT01742702
First received: November 29, 2012
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Primary Hypertension Secondary Hypertension Aortic Stenosis Renal Insufficiency Drug: Nitroglycerin 0.25 mg (single dose) Drug: Salbutamol 400 µg (single dose) Drug: L-arginine (10 min infusion) Dietary Supplement: Liquorice (2 weeks, glycyrrhizin 290-370 mg daily) Dietary Supplement: Small milk casein-derived polypeptides (12 weeks daily) Drug: Bisoprolol (5mg daily for 3 weeks)

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Non-Invasive HaemoDYNAMICs in Primary and Secondary Hypertension: the DYNAMIC-study

Resource links provided by NLM:


Further study details as provided by Ilkka Porsti, University of Tampere:

Primary Outcome Measures:
  • Change in haemodynamic variables during the follow-up [ Time Frame: baseline, one year, ten years ]
    Haemodynamic measurements are performed at baseline, after one year and after approximately 10 years of follow-up


Secondary Outcome Measures:
  • Haemodynamic response to head-up tilt and research drugs [ Time Frame: 0, 5, 10, 15, 20, 25 and 30 minutes ]
    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)

  • Haemodynamic response to bisoprolol or dietary supplements (liquorice, milk casein-derived polypeptides) [ Time Frame: 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)


Biospecimen Retention:   Samples With DNA
Whole blood, serum, urine

Estimated Enrollment: 2000
Actual Study Start Date: May 25, 2006
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DYNAMIC
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.
Drug: Nitroglycerin 0.25 mg (single dose)
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).
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
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).
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
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.
Drug: Nitroglycerin 0.25 mg (single dose)
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).
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
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).
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
Liquorice (recordings completed)
Normotensive subjects, daily liquorice ingestion (daily glycyrrhizin dose 290-370 mg) for 2 weeks, haemodynamic measurements before and after the intervention.
Drug: Nitroglycerin 0.25 mg (single dose)
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).
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
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).
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
Dietary Supplement: Liquorice (2 weeks, glycyrrhizin 290-370 mg daily)
Daily liquorice intake (daily glycyrrhizin dose 290-370 mg) for two weeks, measurements before and after intervention (recordings completed).
Other Name: Halva liquorice (TM), Kouvola liquorice (TM)
Milk polypeptides (recordings completed)
Daily ingestion of yoghurt containing small milk casein-derived polypeptides for 12 weeks versus placebo yoghurt.
Dietary Supplement: Small milk casein-derived polypeptides (12 weeks daily)
Daily intake of yoghurt containing small milk casein-derived polypeptides (12 weeks) and placebo yoghurt (12 weeks), measurements before and after intervention (recordings completed).
Other Name: Valio (TM) evolus yoghurt
Bisoprolol (recordings completed)
Hypertensive subjects, bisoprolol 5 mg once daily versus placebo in a double-blind, cross-over protocol.
Drug: Nitroglycerin 0.25 mg (single dose)
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).
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
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).
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
Drug: Bisoprolol (5mg daily for 3 weeks)
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).
Other Name: Emconcor 5 mg, Merck KGaA, Darmstadt, Germany
Aortic stenosis
Subjects with aortic stenosis confirmed by echocardiography
Drug: Nitroglycerin 0.25 mg (single dose)
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).
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
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).
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
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
Drug: Nitroglycerin 0.25 mg (single dose)
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).
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
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).
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
Drug: L-arginine (10 min infusion)
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).
Other Name: L-arginine HCl 20 mg ml/l, B. Braun Ag, Melsungen, Germany

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).

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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 in several occupational health care providers in the Pirkanmaa Hospital District.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Systolic blood pressure <90 mmHg
  • Allergies to test compounds
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742702

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Ilkka Pörsti, Professor       ilkka.porsti@uta.fi   
Principal Investigator: Ilkka Pörsti, MD, PhD, Professor         
University of Tampere Recruiting
Tampere, Finland
Contact: Ilkka Pörsti, MD, PhD, Professor       ilkka.porsti@uta.fi   
Principal Investigator: Ilkka Pörsti, Professor         
Sponsors and Collaborators
University of Tampere
Finnish Foundation for Cardiovascular Research
Paavo Nurmi Foundation
Sigrid Jusélius Foundation
Finnish Cultural Foundation
Tampere Tuberculosis Foundation
Medical Research Fund of the Tampere University Hospital, Finland
Aarne Koskelo Foundation
Finnish Medical Foundation
Finnish Kidney Foundation
Päivikki and Sakari Sohlberg Foundation, Finland
Investigators
Principal Investigator: Ilkka Pörsti, MD, PhD University of Tampere
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ilkka Porsti, MD, PhD, Professor of Internal Medicine, University of Tampere
ClinicalTrials.gov Identifier: NCT01742702     History of Changes
Other Study ID Numbers: R06086M
2006-002065-39 ( EudraCT Number )
2009-014542-29 ( EudraCT Number )
R07110M ( Other Identifier: Ethics Committee of Pirkanmaa Hospital District )
R07053M ( Other Identifier: Ethics Committee of Pirkanmaa Hospital District )
R08012 ( Other Identifier: Ethics Committee of Pirkanmaa Hospital District )
R09103M ( Other Identifier: Ethics Committee of Pirkanmaa Hospital District )
R10056 ( Other Identifier: Ethics Committee of Pirkanmaa Hospital District )
R06086M ( Other Identifier: Ethics Committee of Pirkanmaa Hospital District )
Study First Received: November 29, 2012
Last Updated: May 2, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Ilkka Porsti, University of Tampere:
Blood pressure
Hypertension
Arterial stiffness
Cardiac output
Vascular resistance
Pulse wave reflection
Head-up tilt

Additional relevant MeSH terms:
Hypertension
Neoplasm Metastasis
Renal Insufficiency
Aortic Valve Stenosis
Vascular Diseases
Cardiovascular Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Kidney Diseases
Urologic Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Bisoprolol
Albuterol
Glycyrrhizic Acid
Nitroglycerin
Caseins
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017