results HYVET 2: treatment of white coat hypertension in the very elderly This study is looking at whether it is possible to run a trial to treat white coat. 17 Aug Given this uncertainty, the Hypertension in the Very Elderly Trial (HYVET) was commissioned with an open label pilot undertaken to determine. 31 Mar The study, called the Hypertension in the Very Elderly Trial (HYVET), was halted in August on the recommendation of the data and safety.
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The treatment steps used in the main trial were indapamide SR 1.
In that vein, some have expressed significant concerns with over-treatment of hypertension in the hyvdt, citing the risks of polypharmacy and the fact that elderly patients are prone to hypovolemia and orthostatic syncope, etc.
Incidence of cardiovascular events by assessing the composition of cardiovascular events on an ongoing basis Sign Up It’s Free! The fact that differences remained in all cause mortality and cardiovascular mortality supports the idea that some benefits from control teial blood pressure take longer to accrue and that early treatment is thus warranted. All reported P values are two sided and not adjusted for multiple testing.
HYVET – Wiki Journal Club
The results should be viewed in the context of those from the main trial as well. Ebrahim S, Kalache A, eds. At jyvet time hyve the start of the extension and for four months afterwards until the freezing of the database for the main trialthe coordinating centre was not supplied with the code to break the blind, so local investigators were not teial whether participants had previously been on active or placebo drug.
Despite this, differences in total mortality and cardiovascular mortality remained during the extension, indicating that reductions in these major end points are likely to take a longer time to accrue. As in the active arm of the trial, most participants approximately three quarters needed combination therapy of indapamide SR and perindopril at either the 2 mg or 4 mg dosage.
For those who were illiterate, an independent witness signed the consent form. No other exclusion criteria for the extension were considered. The code for breaking of the blind was not provided to the coordinating centre until five months after the final visits, so we could not do power calculations on the basis of the collected data. Not available in web format, please use the contact details to request a patient information sheet.
Ambulatory and home blood pressure mmHg measured on an ongoing basis. Park Road Surgery UK 9. Sustained differences in reductions of total mortality and cardiovascular mortality reinforce the benefits and support the need for early and long term treatment.
We report here the main findings from the trial extension.
HYVET 2: treatment of white coat hypertension in the very elderly
View popup View inline. The data remain the intellectual property of Imperial College London, but confidential data sharing agreements may hyvef entered into to address the original premise of the trial.
No additional information was collected on the participants 85 in each group who did not consent to enter the open label extension or the participants who were on open label treatment at the end of the main trial. Any stroke or myocardial infarction in the previous 6 months 7. Research Immediate and late benefits of treating very elderly people with hypertension: This design will gather preliminary information on the intervention and hyveh feasibility of conducting a full-scale randomised controlled trial.
We took a P value of 0. Contraindication to the use of indapamide MR and perindopril in accordance with the summary of product characteristics 2.
The opportunities for PPI patient and public involvement in the research design and its trizl conduct and dissemination. Although significant differences in total mortality remained during the extension, the rates were lower than hyvdt the main trial. Regular use being defined by the local GP with consideration to cardiovascular risk and blood pressure 3. Similarly, we found no differences between the two groups for heart failure events hazard ratio 0.
Strength and limitations One of the main limitations of the HYVET extension was that hvet participants who were on double blind treatment were enrolled from the main trial. At this time, final data were being collected and cleaned, so the exact rates and differences between the two original groups were not known.
To be eligible for entry into the main trial, participants had to be aged 80 years or over with sustained levels of systolic blood pressure of mm Hg or above over a two month placebo run-in phase.
At three and six monthly visits, only information on current diseases, drug treatment, and blood pressure was collected. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license.
There were also significant reductions in rates of other secondary outcomes including fatal stroke, HF, and CV events.
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Given this, and that the existing trial was to run seamlessly into the extension, we did not do revised power calculations. For participants with more than one end point, we used time to the first relevant end point in each analysis. Even at the age of 80, average life expectancy can be around seven years for men and nine years for women. Previous documented evidence of gout 9.
By six months, little difference existed in the number at any particular treatment step between participants previously taking active drug and those previously taking placebo. That does not mean that all would benefit from antihypertensive treatment.
All final visits related to the main trial were completed by 12 October Other intervention trials in hypertension have also reassessed the long term outcomes of participants originally included in the trial.