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Arterial Hypertension | Non-invasive Haemodynamic Assessment in Hypertension

Arterial Hypertension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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),

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arterial Hypertension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:lisinoprilAngiotensin converting enzyme inhibitor recommended in case of: "hyperconstrictive" profile (SVRI > 2500-2800 dyn•s•cm-5•m2) "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) "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) "balanced" profile

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

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

Drug:Indapamide/hydrochlorothiazide"hypervolemic" profile (man - TFC > 34 1/kOhm; women - TFC > 24 1/kOhm) "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:Amlodipine1/ SVRI > 2800 dyn•s•cm-5•m2 (in combination with lisinopril/telmisartan)

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

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

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

Drug:Indapamide/hydrochlorothiazideDrug choice at the discretion of physician (blinded to ICG)

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Hemodynamic groupThe treatment choice based on hemodynamic parameters established with ICG method. Monotherapy or combined therapy in case of 1/ complex hemodynamic disturbances and/or 2/ 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

Empiric GroupThe treatment choice based on current guidelines (blinded to ICG). Monotherapy or combined therapy in case of 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

Study Status

Completed

Start Date: January 2013

Completed Date: December 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 24-h mean Systolic Blood Pressure (in ABPM)

Secondary Outcome: change from baseline in Systolic Blood Pressure (in OBPM) at 3 months

Study sponsors, principal investigator, and references

Principal Investigator: Pawel Krzesinski, MD, PhD

Lead Sponsor: Military Institute of Medicine, Poland

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01996085

Ventura HO, Taler SJ, Strobeck JE. Hypertension as a hemodynamic disease: the role of impedance cardiography in diagnostic, prognostic, and therapeutic decision making. Am J Hypertens. 2005 Feb;18(2 Pt 2):26S-43S. Review.

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