The Difficult But Important Task of Controlling for Hypertension in Clinical Trials

Whether due to increasingly stressful lifestyles and work environments, poor dietary intakes or smoking, levels of heart disease and hypertension are increasing across both the developed world and even in developing countries such as China. As a result the demand for effective heart disease and hypertension medications is also rising. To continue to produce newer and better heart disease and hypertension treatments more and more clinical trials must be performed with more effective parameters.

One of the most common barriers that need to be overcome in clinical trials for heart medication is a phenomenon known as the white coat hypertension effect. This is when unreliable blood pressure readings are gathered in clinical settings. The results are considered unreliable because the clinical environment, where patients or participants are surrounded by nurses, hospital equipment and doctors in white coats and develop hypertension as a result of being in an intimidating or stressful setting.

Controlling for white coat hypertension is an important part of any clinical trials where blood pressure readings are part of the determining data. Inaccurate readings due to white coat hypertension could undermine the actual efficacy of drugs, particularly drugs used to treat hypertension, giving the appearance that they are less effective than they actually are. Due to the high cost of running trials and the financial implications for the production of the drug it is critical to control for white coat hypertension.

One of the simplest ways to control for this kind of hypertension in clinical trials is through ambulatory blood pressure monitoring. This is where the blood pressure of participants is measured at regular intervals over a twenty four hour period. This gives the patient or participant time to adjust to the test environment and give normal readings unaffected by hypertension.

Sometimes this type of ambulatory BP monitoring is inadequate for the requirements of certain clinical trials. The clinical setting may not reflect the normal variation of blood pressure even when the patient has acclimatised to correct for the white coat hypertension effect. In this case the patient or participant can be fitted with a personal blood pressure monitor. This is a device that can continuously monitor blood pressure throughout the day. One advantage of this product is that is can provide a continuous chart that shows fluctuations throughout the day and night. This can reveal information about the participant's blood pressure variation with the circadian rhythm.

Another benefit is that it records the participant's blood pressure as they go about their daily routine. Normal incidents such as being stuck in traffic or enduring a particularly stressful day at work can cause hypertension and other changes. Looking at this information in the course of a trial can show how the product or medicine being trialled effects and is affected by these normal occurrences.

In order to continue producing effective and comprehensive treatments for heart conditions clinical trials must constantly be improved to find better ways of controlling for white coat hypertension and other effects.

Java Clinical provides clinical trials in clinical trials in Europe and Ireland in a variety of therapeutic areas such as hypertension, respiratory, endocrinology, neurology and more. http://www.javacr.com/


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