Non-invasive Haemodynamic Assessment in Hypertension

Summary

Arterial hypertension (AH) is an important clinical social and economic problem. In the pathogenesis of AH increased BP is a result of complex mechanisms i. e. fluid retention, increased vascular resistance and hyperkinetic heart function. Impedance cardiography (ICG) is a simple and safe, non-invasive method of hemodynamic monitoring which allows simultaneous assessment of i. e. BP, cardiac index, heart rate, the fluid content in the chest and systemic vascular resistance.

The detailed effect of treatment based on ICG has not been evaluated so far in the long-term observation and for other clinically relevant parameters, such as central blood pressure, left ventricular hypertrophy, metabolic disturbances, parameters of antioxidative-oxidative balance and endothelial function. Therefore, the following main objectives of the study were defined:

* Evaluation of usefulness of impedance cardiography in optimizing treatment of patients with hypertension in the area of reduction and control of blood pressure, hemodynamic parameters, biochemical markers and quality of life.
* Evaluation of complex pathophysiological mechanisms associated with hypertension including hemodynamic, anthropometric, psychological and biochemical parameters as well as the effect of antihypertensive treatment on these phenomena.

The study will be randomized (1:1), prospective and controlled in parallel with conventional treatment. The subjects will be divided into groups according to the pre-established random order:

1. empiric group (GE), in which treatment choice will be based on clinical data and current guidelines
2. hemodynamic group (HD), in which treatment choice will be based on clinical data and current guidelines considering hemodynamic parameters established with ICG method.

All patients will undergo a detailed examination three times: before treatment, then after 3 and 12 months of treatment.

The authors expect that the study will consolidate the importance of ICG in the diagnosis of patients with AH. Simultaneous multiparametric evaluation of the subjects guarantees a unique and innovative results which can enhance our knowledge in pathophysiology of AH and reversibility of adverse mechanisms associated with this disease.

Conditions

• Arterial Hypertension

Interventions

DRUG

lisinopril

Angiotensin converting enzyme inhibitor recommended in case of: 1. "hyperconstrictive" profile (SVRI \> 2500-2800 dyn•s•cm-5•m2) 2. "hyperdynamic" profile (CI \> 4.2 l/min/m2 and/or HR \> 80/min) and office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg (in combination with nebivolol) 3. "hypervolemic" profile (man - TFC \> 34 1/kOhm; women - TFC \> 24 1/kOhm) and office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg (in combination with diuretic) 4. "balanced" profile

DRUG

Telmisartan

Angiotensin receptor blocker recommended in terms as for lisinopril in case of its intolerance (e.i. cough)

DRUG

Nebivolol

Beta-blocker recommended in case of: 1."hyperdynamic" profile (CI \> 4.2 l/min/m2 and/or HR \> 80/min)

DRUG

Indapamide/hydrochlorothiazide

1. "hypervolemic" profile (man - TFC \> 34 1/kOhm; women - TFC \> 24 1/kOhm) 2. "hyperconstrictive" profile (SVRI \> 2500-2800 dyn•s•cm-5•m2) and office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg (in combination with lisinopril/telmisartan)

DRUG

Amlodipine

1/ SVRI \> 2800 dyn•s•cm-5•m2 (in combination with lisinopril/telmisartan)

DRUG

lisinopril

Drug choice at the discretion of physician (blinded to ICG)

DRUG

Telmisartan

Angiotensin receptor blocker recommended as for lisinopril in case of its intolerance (e.i. cough)

DRUG

Nebivolol

Drug choice at the discretion of physician (blinded to ICG)

DRUG

Indapamide/hydrochlorothiazide

Drug choice at the discretion of physician (blinded to ICG)

DRUG

Amlodipine

Drug choice at the discretion of physician (blinded to ICG)

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute

  lead OTHER

Principal Investigators

• Pawel Krzesinski, MD, PhD · Department of Cardiology and Internal Diseases, Military Institute of Medicine, Poland

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2016-06-30

Completion

2017-12-31

Countries

• Poland

Study Locations