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Trial record 71 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Non-invasive Haemodynamic Assessment in Hypertension (FINE-PATH)

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ClinicalTrials.gov Identifier: NCT01996085
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Paweł Krzesiński, Military Institute of Medicine, Poland

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:

  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.


Condition or disease Intervention/treatment Phase
Arterial Hypertension Drug: lisinopril Drug: Telmisartan Drug: Nebivolol Drug: Indapamide/hydrochlorothiazide Drug: Amlodipine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Usefulness of Non-invasive Assessment of Haemodynamic Profile in the Diagnosis and Treatment of Hypertension
Actual Study Start Date : January 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hemodynamic group

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

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)

Active Comparator: Empiric Group

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 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)




Primary Outcome Measures :
  1. 24-h mean Systolic Blood Pressure (in ABPM) [ Time Frame: after 3 months from recruitment ]
  2. 24-h mean Diastolic Blood Pressure (in ABPM) [ Time Frame: after 3 months from recruitment ]
  3. daytime mean Systolic Blood Pressure (in ABPM) [ Time Frame: after 3 months from recruitment ]
  4. daytime mean Diastolic Blood Pressure (in ABPM) [ Time Frame: after 3 months from recruitment ]
  5. night-time mean Systolic Blood Pressure (in ABPM) [ Time Frame: after 3 months from recruitment ]
  6. night-time mean Diastolic Blood Pressure (in ABPM) [ Time Frame: after 3 months from recruitment ]
  7. Systolic Blood Pressure (in OBPM) [ Time Frame: after 3 months from recruitment ]
  8. Diastolic Blood Pressure (in OBPM) [ Time Frame: after 3 months from recruitment ]
  9. 24-h mean Systolic Blood Pressure (in ABPM) [ Time Frame: after 12 months from recruitment ]
  10. 24-h mean Diastolic Blood Pressure (in ABPM) [ Time Frame: after 12 months from recruitment ]
  11. daytime mean Systolic Blood Pressure (in ABPM) [ Time Frame: after 12 months from recruitment ]
  12. daytime mean Diastolic Blood Pressure (in ABPM) [ Time Frame: after 12 months from recruitment ]
  13. night-time mean Systolic Blood Pressure (in ABPM) [ Time Frame: after 12 months from recruitment ]
  14. night-time mean Diastolic Blood Pressure (in ABPM) [ Time Frame: after 12 months from recruitment ]
  15. Systolic Blood Pressure (in OBPM) [ Time Frame: after 12 months from recruitment ]
  16. Diastolic Blood Pressure (in OBPM) [ Time Frame: after 12 months from recruitment ]

Secondary Outcome Measures :
  1. change from baseline in Systolic Blood Pressure (in OBPM) at 3 months [ Time Frame: after 3 months from recruitment ]
  2. change from baseline in Diastolic Blood Pressure (in OBPM) at 3 months [ Time Frame: after 3 months from recruitment ]
  3. change from baseline in 24-h Systolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 3 months from recruitment ]
  4. change from baseline in 24-h Diastolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 3 months from recruitment ]
  5. change from baseline in daytime Systolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 3 months from recruitment ]
  6. change from baseline in daytime Diastolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 3 months from recruitment ]
  7. change from baseline in night-time Systolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 3 months from recruitment ]
  8. change from baseline in night-time Diastolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 3 months from recruitment ]
  9. change from baseline in Systolic Blood Pressure (in OBPM) at 3 months [ Time Frame: after 12 months from recruitment ]
  10. change from baseline in Diastolic Blood Pressure (in OBPM) at 3 months [ Time Frame: after 12 months from recruitment ]
  11. change from baseline in 24-h Systolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 12 months from recruitment ]
  12. change from baseline in 24-h Diastolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 12 months from recruitment ]
  13. change from baseline in daytime Systolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 12 months from recruitment ]
  14. change from baseline in daytime Diastolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 12 months from recruitment ]
  15. change from baseline in night-time Systolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 12 months from recruitment ]
  16. change from baseline in night-time Diastolic Blood Pressure (in ABPM) at 3 months [ Time Frame: after 12 months from recruitment ]

Other Outcome Measures:
  1. Heart Rate (HR) [ Time Frame: after 3 months from recruitment ]
  2. Cardiac Index (CI) [ Time Frame: after 3 months from recruitment ]
  3. Thoracic Fluid Content (TFC) [ Time Frame: after 3 months from recruitment ]
  4. Systemic Vascular Resistance Index (SVRI) [ Time Frame: after 3 months from recruitment ]
  5. augmentation index (AAI) [ Time Frame: after 3 months from recruitment ]
  6. Central Systolic Blood Pressure [ Time Frame: after 3 months from recruitment ]
  7. Central Diastolic Blood Pressure [ Time Frame: after 3 months from recruitment ]
  8. Flow-mediated Dilatation (FMD) [ Time Frame: after 3 months from recruitment ]
  9. Heart Rate (HR) [ Time Frame: after 12 months from recruitment ]
  10. Cardiac Index (CI) [ Time Frame: after 12 months from recruitment ]
  11. Thoracic Fluid Content (TFC) [ Time Frame: after 12 months from recruitment ]
  12. Systemic Vascular Resistance Index (SVRI) [ Time Frame: after 12 months from recruitment ]
  13. augmentation index (AAI) [ Time Frame: after 12 months from recruitment ]
  14. Central Systolic Blood Pressure [ Time Frame: after 12 months from recruitment ]
  15. Central Diastolic Blood Pressure [ Time Frame: after 12 months from recruitment ]
  16. Flow-mediated Dilatation (FMD) [ Time Frame: after 12 months from recruitment ]
  17. left ventricular mass index(LVMI) [ Time Frame: after 12 months from recruitment ]
  18. change from baseline in Heart Rate (HR) at 3 months [ Time Frame: after 3 months from recruitment ]
  19. change from baseline in Cardiac Index (CI) at 3 months [ Time Frame: after 3 months from recruitment ]
  20. change from baseline in Thoracic Fluid Content (TFC) at 3 months [ Time Frame: after 3 months from recruitment ]
  21. change from baseline in Systemic Vascular Resistance Index (SVRI) at 3 months [ Time Frame: after 3 months from recruitment ]
  22. change from baseline in augmentation index (AAI) at 3 months [ Time Frame: after 3 months from recruitment ]
  23. change from baseline in Central Systolic Blood Pressure at 3 months [ Time Frame: after 3 months from recruitment ]
  24. change from baseline in Central Diastolic Blood Pressure at 3 months [ Time Frame: after 3 months from recruitment ]
  25. change from baseline in Flow-mediated Dilatation (FMD) at 3 months [ Time Frame: after 3 months from recruitment ]
  26. change from baseline in Heart Rate (HR) at 12 months [ Time Frame: after 12 months from recruitment ]
  27. change from baseline in Cardiac Index (CI) at 12 months [ Time Frame: after 12 months from recruitment ]
  28. change from baseline in Thoracic Fluid Content (TFC) at 12 months [ Time Frame: after 12 months from recruitment ]
  29. change from baseline in Systemic Vascular Resistance Index (SVRI) at 12 months [ Time Frame: after 12 months from recruitment ]
  30. change from baseline in augmentation index (AAI) at 12 months [ Time Frame: after 12 months from recruitment ]
  31. change from baseline in Central Systolic Blood Pressure at 12 months [ Time Frame: after 12 months from recruitment ]
  32. change from baseline in Central Diastolic Blood Pressure at 12 months [ Time Frame: after 12 months from recruitment ]
  33. change from baseline in Flow-mediated Dilatation (FMD) at 12 months [ Time Frame: after 12 months from recruitment ]
  34. change from baseline in left ventricular mass index (LVMI) at 12 months [ Time Frame: after 12 months from recruitment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996085


Locations
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Poland
Military Institute of Medicine
Warsaw, Mazovia, Poland, 04-141
Sponsors and Collaborators
Military Institute of Medicine, Poland
Investigators
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Principal Investigator: Pawel Krzesinski, MD, PhD Department of Cardiology and Internal Diseases, Military Institute of Medicine, Poland

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paweł Krzesiński, MD, PhD, Assistant Lecturer in the Department of Cardiology and Internal Diseases, Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier: NCT01996085     History of Changes
Other Study ID Numbers: WIM-0000000148
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Keywords provided by Paweł Krzesiński, Military Institute of Medicine, Poland:
arterial hypertension
hemodynamics
impedance cardiography
hypotensive therapy
Additional relevant MeSH terms:
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Hydrochlorothiazide
Telmisartan
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Nebivolol
Lisinopril
Indapamide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents