Hypertension increased blood pressure
Conditions
Interventions
Once daily doses of aliskiren (300 mg), moxonidine (0,4 mg), HCTZ (25 mg) and
placebo following standardised 8-week treatment schedules. Participants receive
all four interventions in a randomized a
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is a male of 30-70 years of age on the day of signing informed consent. ;All patients should fulfil the diagnostic criterion of abdominal adiposity: waist circumference > 102 cm. The waist circumference is measured halfway between the lower rib and iliac crest in standing position.;All patients should fulfil one of the following diagnostic criteria for hypertension: - SBP >//// 1.7 mmol/L); - Low High-density lipoprotein (HDL)-cholesterol (serum HDL-cholesterol 5.6 mmol/L).;Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
Exclusion criteria
Exclusion criteria: SBP > 180 mmHg and/or DBP > 110 mmHg during one or more screening measurements and/or use of more than one type of antihypertensive medication.;Ten year cardiovascular mortality risk according to the SCORE-risk model > 10% ;BMI > 35 kg/m2;Current smoking or smoking during the previous 3 months;Use of *recreational* or illicit drugs;Recent history (within the last year) of alcohol abuse or dependence.;History of hypersensitivity reactions or intolerance to any (components of) medication used in this trial.;Current / recent participation (within 30 days of signing informed consent) in a study with an investigational compound or device.;Laboratory values as listed below: - Hemoglobin (Hb) 5.0 mcIU/mL - Potassium 5,0 mmol/L - Sodium 146 mmol/L - MDRD 50% obstruction of a carotid artery]). - Cardiac arrhythmia*s, for example bradycardia, atrial fibrillation, sick-sinus syndrome, sinoatrial block, atriovertricular block or any other arrhythmia. - Obstructive sleep apnea syndrome (OSAS) or a score of 10 or higher on the Epworth Sleepiness Scale questionnaire. - Type 2 diabetes mellitus - Serious liver function disorders (Child-Pugh-Class C). - COPD (GOLD classification of severity 2 or higher) - Celiac disease or other significant intestinal malabsorption - Malignancy * 5 years prior to signing informed consent, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer. - Mental instability or major psychiatric illness - Polyneuropathy or clinical suspicion for autonomic nervous system dysfunction. - Any diseases that would limit or complicate study evaluation or participation. - Any diseases or screening abnormalities that call for treatment that can not be postponed until after the study period without causing harm. ;Any concomitant medication, particularly antihypertensive co-medication, glucose lowering medication, lipid lowering drugs, systemic corticosteroids, birth control pills and vitamin C or E supplements, but also any other kinds of drugs, including over the counter medication. Exceptions can be made for the following categories of drugs: - paracetamol; - proton-pump inhibitors; - topical creams and unguents that do not lead to uptake of any of the active components into the circulation (in case of steroid creams: class II or lower); - inhalation medication, nasal sprays and eye drops that do not lead to uptake of any of the active components into the circulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean intrapersonal changes in endothelial function (FMD). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean intrapersonal changes in serum adipokine concentrations, serum lipid concentrations, HOMA, mean 24-hour SBP/DBP, mean day/night time SBP/DBP, central blood pressure (PWA), serum and urine concentrations of markers of oxidative stress, serum concentrations of markers of systemic inflammation, arterial stiffness (PWV, PWA), RAS-hormone concentrations, MSNA, HRV, fractional sodium excretion. | — |
Countries
Netherlands
Outcome results
None listed