Non-invasive Haemodynamic Assessment in Hypertension

NCT01996085 | Completed

• 1 other identifier: WIM-0000000148
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

Arterial Hypertension

Keywords

arterial hypertension; hemodynamics; impedance cardiography; hypotensive therapy

Outcome Measures

Primary Outcomes (16)

• 24-h mean Systolic Blood Pressure (in ABPM)

  after 3 months from recruitment

• 24-h mean Diastolic Blood Pressure (in ABPM)

  after 3 months from recruitment

• daytime mean Systolic Blood Pressure (in ABPM)

  after 3 months from recruitment

• daytime mean Diastolic Blood Pressure (in ABPM)

  after 3 months from recruitment

• night-time mean Systolic Blood Pressure (in ABPM)

  after 3 months from recruitment

• night-time mean Diastolic Blood Pressure (in ABPM)

  after 3 months from recruitment

• Systolic Blood Pressure (in OBPM)

  after 3 months from recruitment

• Diastolic Blood Pressure (in OBPM)

  after 3 months from recruitment

• 24-h mean Systolic Blood Pressure (in ABPM)

  after 12 months from recruitment

• 24-h mean Diastolic Blood Pressure (in ABPM)

  after 12 months from recruitment

• daytime mean Systolic Blood Pressure (in ABPM)

  after 12 months from recruitment

• daytime mean Diastolic Blood Pressure (in ABPM)

  after 12 months from recruitment

• night-time mean Systolic Blood Pressure (in ABPM)

  after 12 months from recruitment

• night-time mean Diastolic Blood Pressure (in ABPM)

  after 12 months from recruitment

• Systolic Blood Pressure (in OBPM)

  after 12 months from recruitment

• Diastolic Blood Pressure (in OBPM)

  after 12 months from recruitment

Secondary Outcomes (16)

• change from baseline in Systolic Blood Pressure (in OBPM) at 3 months

  after 3 months from recruitment

• change from baseline in Diastolic Blood Pressure (in OBPM) at 3 months

  after 3 months from recruitment

• change from baseline in 24-h Systolic Blood Pressure (in ABPM) at 3 months

  after 3 months from recruitment

• change from baseline in 24-h Diastolic Blood Pressure (in ABPM) at 3 months

  after 3 months from recruitment

• change from baseline in daytime Systolic Blood Pressure (in ABPM) at 3 months

  after 3 months from recruitment

Other Outcomes (34)

• Heart Rate (HR)

  after 3 months from recruitment

• Cardiac Index (CI)

  after 3 months from recruitment

• Thoracic Fluid Content (TFC)

  after 3 months from recruitment

Study Arms (2)

Hemodynamic group

EXPERIMENTAL

The 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

Drug: lisinopril; Drug: Telmisartan; Drug: Nebivolol; Drug: Indapamide/hydrochlorothiazide; Drug: Amlodipine

Empiric Group

ACTIVE COMPARATOR

The 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

Drug: lisinopril; Drug: Telmisartan; Drug: Nebivolol; Drug: Indapamide/hydrochlorothiazide; Drug: Amlodipine

Interventions

lisinopril DRUG

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

Hemodynamic group

Telmisartan DRUG

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

Hemodynamic group

Nebivolol DRUG

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

Hemodynamic group

Indapamide/hydrochlorothiazide DRUG

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)

Hemodynamic group

Amlodipine DRUG

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

Hemodynamic group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, Masovian Voivodeship, 04-141, Poland

Location

Related Publications (7)

• 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.

  PMID: 15752931 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.

  PMID: 12019280 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.

  PMID: 16520405 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.

  PMID: 20042450 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.

  PMID: 15752930 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.

  PMID: 19253194 BACKGROUND

• 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.

  PMID: 26876066 DERIVED

Related Links

• Project's description in national database

MeSH Terms

Conditions

Hypertension

Interventions

Lisinopril; Telmisartan; Nebivolol; Indapamide; Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Indoles; Chlorothiazide; Benzothiadiazines; Thiazides; Dihydropyridines; Pyridines

Study Officials

• Pawel Krzesinski, MD, PhD

  Department of Cardiology and Internal Diseases, Military Institute of Medicine, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant Lecturer in the Department of Cardiology and Internal Diseases

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 27, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

PL (1)