Haemodynamics in Hypertension (DYNAMIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Tampere
Sponsor:
Collaborators:
Finnish Foundation for Cardiovascular Research
Paavo Nurmi Foundation
Sigrid Juselius Foundation
Finnish Cultural Foundation
Tampere Tuberculosis Foundation
The Competitive Research Funding of Pirkanmaa Hospital District
Aarne Koskelo Foundation
Finnish Medical Foundation
Orion Farmos Research Foundation
Finnish Kidney Foundation
Information provided by (Responsible Party):
Ilkka Porsti, University of Tampere
ClinicalTrials.gov Identifier:
NCT01742702
First received: November 29, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

The aim of the present study was to examine the haemodynamic changes in primary and secondary 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.


Condition Intervention Phase
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 (yoghurt, 12 weeks daily)
Drug: Bisoprolol (5mg daily for 3 weeks)
Phase 0

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

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Change in haemodynamic variables during the follow-up [ Time Frame: baseline, one year, ten years ] [ Designated as safety issue: No ]
    Haemodynamic measurements are performed at baseline, after one year and after 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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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
Study Start Date: June 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DYNAMIC
Subjects with primary or secondary hypertension and normotensive control subjects
Drug: Nitroglycerin 0.25 mg (single dose)
Single dose of sublingual nitroglycerin to examine acute haemodynamic effects
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
Single dose of inhaled salbutamol to examine acute haemodynamic effects
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
AERO-DYNAMIC
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)
Single dose of sublingual nitroglycerin to examine acute haemodynamic effects
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
Single dose of inhaled salbutamol to examine acute haemodynamic effects
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
Liquorice
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)
Single dose of sublingual nitroglycerin to examine acute haemodynamic effects
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
Single dose of inhaled salbutamol to examine acute haemodynamic effects
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
Other Name: Halva liquorice (TM), Kouvola liquorice (TM)
Milk polypeptides
Daily ingestion of yoghurt containing small milk casein-derived polypeptides for 12 weeks versus placebo yoghurt.
Dietary Supplement: Small milk casein-derived polypeptides (yoghurt, 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
Other Name: Valio (TM) evolus yoghurt
Bisoprolol
Hypertensive subjects, bisoprolol 5 mg once daily versus placebo in a double-blind, cross-over protocol.
Drug: Nitroglycerin 0.25 mg (single dose)
Single dose of sublingual nitroglycerin to examine acute haemodynamic effects
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
Single dose of inhaled salbutamol to examine acute haemodynamic effects
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.
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)
Single dose of sublingual nitroglycerin to examine acute haemodynamic effects
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
Single dose of inhaled salbutamol to examine acute haemodynamic effects
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
Methodological
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)
Single dose of sublingual nitroglycerin to examine acute haemodynamic effects
Other Name: Nitro resoriblet, Orion Pharma, Espoo, Finland
Drug: Salbutamol 400 µg (single dose)
Single dose of inhaled salbutamol to examine acute haemodynamic effects
Other Name: Ventoline, GlaxoSmithKline, Uxbridge, Middlesex, UK
Drug: L-arginine (10 min infusion)
L-arginine infusion 10 mg/kg/min for 10 minutes to examine acute haemodynamic effects
Other Name: L-arginine hydrochloride 20 mg ml/l, B. Braun Melsungen 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 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 to the protocol to assess functional haemodynamic status. In addition, 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. 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 study population consists of 7 subgroups, as 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 and older
Genders Eligible for Study:   Both
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 Juselius Foundation
Finnish Cultural Foundation
Tampere Tuberculosis Foundation
The Competitive Research Funding of Pirkanmaa Hospital District
Aarne Koskelo Foundation
Finnish Medical Foundation
Orion Farmos Research Foundation
Finnish Kidney Foundation
Investigators
Principal Investigator: Ilkka Pörsti, MD, PhD, Professor University of Tampere
  More Information

No publications provided by University of Tampere

Additional 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, 2009-014542-29, R07110M, R07053M, R08012, R09103M, R10056, R06086M
Study First Received: November 29, 2012
Last Updated: December 3, 2012
Health Authority: Finland: Finnish National Agency for Medicines

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

Additional relevant MeSH terms:
Hypertension
Aortic Valve Stenosis
Neoplasm Metastasis
Renal Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Kidney Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Urologic Diseases
Vascular Diseases
Ventricular Outflow Obstruction
Albuterol
Bisoprolol
Glycyrrhizic Acid
Nitroglycerin
Adrenergic Agents
Adrenergic Agonists
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic beta-Antagonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antihypertensive Agents
Autonomic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014