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.
Timeline
- Start
- 2013-01
- Primary completion
- 2016-06
- Completion
- 2017-12
Publications
- Background 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. doi: 10.1016/j.amjhyper.2004.11.002.
- Background Taler SJ, Textor SC, Augustine JE. Resistant hypertension: comparing hemodynamic management to specialist care. Hypertension. 2002 May;39(5):982-8. doi: 10.1161/01.hyp.0000016176.16042.2f.
- Background Smith RD, Levy P, Ferrario CM; Consideration of Noninvasive Hemodynamic Monitoring to Target Reduction of Blood Pressure Levels Study Group. Value of noninvasive hemodynamics to achieve blood pressure control in hypertensive subjects. Hypertension. 2006 Apr;47(4):771-7. doi: 10.1161/01.HYP.0000209642.11448.e0. Epub 2006 Mar 6.
- Background Ferrario CM, Flack JM, Strobeck JE, Smits G, Peters C. Individualizing hypertension treatment with impedance cardiography: a meta-analysis of published trials. Ther Adv Cardiovasc Dis. 2010 Feb;4(1):5-16. doi: 10.1177/1753944709348236. Epub 2009 Dec 30.
- Background Ferrario CM. New approaches to hypertension management: always reasonable but now necessary. Am J Hypertens. 2005 Feb;18(2 Pt 2):23S-25S. doi: 10.1016/j.amjhyper.2004.11.042. No abstract available.
- Background Krzesinski P, Gielerak G, Kowal J. [Impedance cardiography - a modern tool for monitoring therapy of cardiovascular diseases]. Kardiol Pol. 2009 Jan;67(1):65-71. No abstract available. Polish.
- Krzesinski P, Gielerak G, Stanczyk A, Piotrowicz K, Uzieblo-Zyczkowska B, Banak M, Kurpaska M, Michalczyk L, Jurek A, Wolszczak K, Galas A, Wojcik A, Skrobowski A. The effect of hemodynamically-guided hypotensive therapy in one-year observation: Randomized, prospective and controlled trial (FINEPATH study). Cardiol J. 2016;23(2):132-40. doi: 10.5603/CJ.a2016.0009. Epub 2016 Feb 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amlodipine | Other / unclassified | — | — |
| Comparator | Hydrochlorothiazide | Unknown | — | — |
| Comparator | Indapamide | Small molecule | — | — |
| Comparator | LISINOPRIL ANHYDROUS | Small molecule | — | — |
| Comparator | Nebivolol | Other / unclassified | — | — |
| Comparator | Telmisartan | Other / unclassified | — | — |