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Treatment of Adiposity Related hypErTension (TARGET)

2014-08-27 03:13:08 | BioPortfolio

Summary

High blood pressure (hypertension) is an important cause of myocardial infarction and stroke. High blood pressure often occurs in people who are overweight. These people frequently also have abnormal fat and sugar metabolism. The combination of these problems is called the 'metabolic syndrome'.

People with hypertension and obesity currently receive the same drug therapy as people with hypertension, but without obesity. Different classes of drugs are thought to be equally effective in lowering blood pressure.

Next to lowering blood pressure, hypertension treatment can have additional effects, like changes in blood vessel function (the ability to dilate and constrict) or changes is the metabolism of sugar and fat. Particularly in patients with the metabolic syndrome, these additional effects are thought to be of great importance, because they can influence the risk for cardiovascular diseases.

The blood pressure lowering mechanism differs between classes of blood pressure lowering medication. The purpose of this study is to compare the effects of three types of blood pressure lowering medication belonging to different classes. The main outcomes of interest will be blood vessel function (the ability to dilate and constrict) and blood pressure. Moreover, the effect of treatment on additional outcomes, like metabolism of sugar and fat, will be studied.

Description

Treatment of obesity related hypertension (ORH) is challenging and has become an important global health problem. According to guidelines, most classes of antihypertensives are equally effective for the treatment of hypertension. However, these guidelines are based on evidence from studies in patients with essential hypertension, but without a specific focus on ORH. There is an increasing body of evidence about the complex pathophysiological mechanisms of ORH. Adipose tissue dysfunction is commonly regarded as a common soil that eventually causes up regulation of the sympathetic nervous system (SNS) and the renin-angiotensin-system (RAS). Moreover, development of hypertension is closely related to development of endothelial dysfunction, dyslipidemia and disorders of glucose metabolism. We hypothesize that treatment with antihypertensives that are directed at down regulation of the SNS (moxonidine) and the RAS (aliskiren) will result in more beneficial effects than treatment with a diuretic (hydrochlorothiazide), because the latter reduces blood pressure by inhibition of sodium resorption, without influencing the underlying disease mechanism. The main outcomes of interest are endothelial function and blood pressure, but many secondary outcomes are studied too.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hypertension

Intervention

Aliskiren, Moxonidine, Hydrochlorothiazide, Placebo (for aliskiren), Placebo (for moxonidine and hydrochlorothiazide)

Location

UMC Utrecht
Utrecht
Netherlands
3508 GA

Status

Not yet recruiting

Source

UMC Utrecht

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:08-0400

Clinical Trials [4354 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II Hypertension

This study will assess the efficacy and safety of combination therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension.

A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequate...

Moxonidine in Patients Undergoing Vascular Surgery

Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day befo...

Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients...

Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (...

PubMed Articles [913 Associated PubMed Articles listed on BioPortfolio]

Effect of aliskiren, a direct renin inhibitor, on the protective action of antiepileptic drugs against pentylenetetrazole-induced clonic seizures in mice.

It has been demonstrated that certain angiotensin-converting enzyme (ACE) inhibitors and angiotensin AT receptor antagonists can possess anticonvulsant activity. The purpose of the current study was t...

Aliskiren: Preclinical evidence for the treatment of hyperproliferative skin disorders.

Psoriasis is a complex inflammatory and hyperproliferative skin disease. The pathogenesis and mechanisms involved are not completely understood, which makes treatment a difficult issue. Angiotensin II...

Hydrochlorothiazide use and risk of Merkel cell carcinoma and malignant adnexal skin tumors: A nationwide case-control study.

Hydrochlorothiazide use has been associated with markedly increased risk of squamous cell carcinoma. No previous studies have investigated the association between hydrochlorothiazide use and the risk ...

First identification of a diuretic, hydrochlorothiazide, in hair: application to a doping case and interpretation of the results.

An athlete contested an adverse analytical finding involving hydrochlorothiazide, and requested our laboratory for testing his hair. As there is no reference in the literature about identification of ...

A retrospective study evaluating the tolerability and effectiveness of adjunctive antihypertensive drugs in patients with inadequate response to initial treatment.

Real-world tolerability and effectiveness of nebivolol as first add-on therapy were compared with hydrochlorothiazide, metoprolol, and amlodipine. Medical records of hypertensive adults initiating neb...

Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A thiazide diuretic with actions and uses similar to those of HYDROCHLOROTHIAZIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p812)

A thiazide diuretic with actions and uses similar to those of HYDROCHLOROTHIAZIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p822)

A thiazide diuretic with properties similar to those of HYDROCHLOROTHIAZIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p825)

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