Clinical Trial in Patients With Hypertension and Left Ventricular Dysfunction
Condition: Hypertension; Cardiac Arrhythmias; Diabetes Mellitus; Renal Insufficiency; Sleep Apnea
MeSH terms: Renal Insufficiency; Hypertension; Arrhythmias, Cardiac; Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Observational

Summary: 
      Arterial hypertension causes adverse effects on the entire cardiovascular system, with
      effects centrally such as diastolic dysfunction and structural changes of the left ventricle
      and, peripherally such as endothelial dysfunction and increased thickness of the vessels.

      Co-existing diseases, such as diabetes mellitus, renal dysfunction, sleep apnea, etc. further
      aggravate the prognosis of these patients.

      In addition the rate of patients aged > 65 years suffering from un-diagnosed or diagnosed
      arterial hypertension was 78% for women and 64% for male patients. This population consists
      from elderly or very elderly patients (over 65 and 80 years respectively) who exhibit more
      comorbidities and probably less compliance with antihypertensive therapy. Finally, at every
      age the disease and its effects can affect the quality of life of patients.

      The main purpose of this study is to investigate the efficacy of antihypertensive therapy
      (irbesartan alone or in combination with amplodipine and carvedilol) on the cardiovascular
      system (diastolic left ventricular function, the function of the endothelium (FMD) and the
      thickness of the common carotid artery).

      The secondary objective of the study is to monitor the quality of life (Quality of Life -
      QoL) of patients.

      Additionally the investigators will seek the correlation of results with co-morbidities,
      compliance, and patient age.
    

Detailed description: 
      The scope of this entire study is to examine the patients as follows::

      Complete Echocardiographic Study including the index of left ventricular mass and relative
      wall thickness (RWT), measurement acquired from left parasternal longitudinal axis.

      Further assessment will be diastolic function and filling pressures of the left ventricle
      using all indices of diastolic function that can be applied in patients with preserved
      ejection fraction according to the relevant guidelines of the European Society of Cardiology
      .

      This will include the tissue velocities of the mitral annulus (lateral, septal and average)
      and the ratio of early diastolic transmitral speed to early diastolic mitral annulus
      velocity.

      The flow of the right upper pulmonary vein , will be recorded during the reverse wave. The
      flow in pulmonary veins (average of 3 different measurements) will be recorded additionally.
      The transmitral A wave duration will also be measured, with the Pulsed Doppler sample volume
      placed at the level of the mitral annulus (average of 3 different measures). The time
      difference between the Ar-A (reverse pulmonary venous - transmitral flow A wave) will be
      calculated .

      The percentage change of E/A ratio with Valsalva will only be calculated in those patients
      who perform a substantial Valsalva manoeuvre, as an absolute decrease of E wave at least 20
      cm / s.

      Left atrial volume index (LAVI) and right ventricular systolic pressure (RVSP) will also be
      estimated.

      Besides left ventricular diastolic function and filling pressures, investigators will also
      estimate the diameter of the ascending aorta and aortic arch (absolute values and indexed for
      body surface area).

      The study of the endothelial function will be done by the method of flow-mediated dilatation
      of the right brachial artery by estimating the FMD.

      Intima-media thickness of common carotic arteries will also be performed.

      Quality of life and level of emotional stress- depression will be assessed with the use of
      specific questionnaires (EQ-5D questionnaires, Short Form 36 health survey questionnaire
      (SF-36), Beck Depression Inventory (BDI)).

      Patient compliance with antihypertensive treatment will be assessed with the following
      questionnaires : Brief Medication Questionnaire 1 (BDQ1), Morisky 8-item Medication Adherence
      Questionnaire.

      Additional evaluations will assess co-morbidities in each patient, taking a detailed medical
      history during the initial diagnostic examination (obstructive sleep apnea , diabetes and
      glycosylated hemoglobin calculation HbA1 , renal impairment by calculating creatinine
      clearance , etc.)

      After 'three months' follow-up investigators will evaluate the efficacy of therapy in the
      regulation of hypertension for all patients. Baseline evaluations will be repeated at three
      months

        -  complete echocardiographic assessment

        -  diastolic left ventricular dysfunction

        -  patients compliance with treatment. Investigators will seek correlations with
           co-morbidities and patient's age.

        -  diastolic left ventricular dysfunction

        -  RWT,

        -  Left ventricular mass index,

        -  LAVI, RVSP,

        -  Ascending Aorta,

        -  Aortic Arch,

        -  FMD,

        -  IMT,

        -  QoL,

        -  emotional stress,

        -  compliance between the two groups, and will seek correlations with co-morbidities and
           patient age.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will recruit 100 patients with hypertension.