Non-invasive Haemodynamic Assessment in Hypertension

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Military Institute of Medicine, Poland
• Treatments: Amlodipine; Angiotensin Receptor Antagonists; Hydrochlorothiazide; Indapamide; Lisinopril; Nebivolol; Telmisartan

Criteria

Inclusion Criteria:

• untreated AH (elevated BP values ≥ 3 months) and insufficiently controlled AH by one or two antihypertensive drugs.

Exclusion Criteria:

• confirmed secondary AH,

• improperly controlled AH with three or more medicines

• chronic renal failure in the third and higher stages of the disease,

• other severe concomitant diseases: systolic heart failure, cardiomyopathy, significant cardiac arrhythmia, significant valvular disease, chronic obstructive pulmonary disease (stage C/D), diabetes, previously undetected, polyneuropathy, peripheral vascular disease,

• body mass index (BMI) > 40 kg/m2,

• mental illness, preventing cooperation with the physician,

• heart rhythm other than sinus (including, i.e. constant heart stimulation),