Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT01742702 |
Other study ID # |
R06086M |
Secondary ID |
2006-002065-3920 |
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 25, 2006 |
Est. completion date |
December 31, 2025 |
Study information
Verified date |
August 2021 |
Source |
Tampere University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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 cardiography in both supine
position and during head-up tilt. For comparison, haemodynamics of subjects with chronic
fatigue syndrome will also be recorded.
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).