Haemodynamics in Hypertension

Condition(s) targeted: Primary Hypertension; Secondary Hypertension; Aortic Stenosis; Renal Insufficiency

Intervention: Nitroglycerin 0.25 mg (single dose) (Drug); Salbutamol 400 µg (single dose) (Drug); L-arginine (10 min infusion) (Drug); Liquorice (2 weeks, glycyrrhizin 290-370 mg daily) (Dietary Supplement); Small milk casein-derived polypeptides (yoghurt, 12 weeks daily) (Dietary Supplement); Bisoprolol (5mg daily for 3 weeks) (Drug)

Phase: Phase 0

Status: Recruiting

Sponsored by: University of Tampere

Official(s) and/or principal investigator(s):
Ilkka Pörsti, MD, PhD, Professor, Principal Investigator, Affiliation: University of Tampere

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.

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

Study design: Time Perspective: Prospective

Primary outcome: Change in haemodynamic variables during the follow-up

Secondary outcome:

Haemodynamic response to head-up tilt and research drugs

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

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Tampere University Hospital, Tampere, Finland; Recruiting
Ilkka Pörsti, Professor, Email: ilkka.porsti@uta.fi
Ilkka Pörsti, MD, PhD, Professor, Principal Investigator

University of Tampere, Tampere, Finland; Recruiting
Ilkka Pörsti, MD, PhD, Professor, Email: ilkka.porsti@uta.fi
Ilkka Pörsti, Professor, Principal Investigator

Starting date: June 2006
Last updated: December 3, 2012