Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

<p>Abstract</p> <p>Background</p> <p>Blood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage.</p> <p>Methods</p> <p>This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution.</p> <p>Discussion</p> <p>The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe in a population-based perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil.</p> <p>Trial Registration</p> <p>Clinical Trials <a href="http://www.clinicaltrials.gov/ct2/show/NCT00970931">NCT00970931</a>.</p

Remodelação cirúrgica da valva aórtica Surgical remodeling of the aortic valve

OBJETIVO: Os autores analisam os resultados por eles obtidos com a utilização de técnica específica para a preservação da valva aórtica. CASUÍSTICA E MÉTODOS: Esse método consiste no emprego habitual da circulação extracorpórea com uso de hipotermia moderada e infusão de solução cardioplégica nos óstios coronários. Realiza-se ressecção da válvula não coronariana e une-se as comissuras correspondentes utilizando-se fio de Mersilene 2-0 ancorado em feltro de teflon, tornando a valva "bivalvulada". Procede-se por fim à aortorrafia convencional. Foram operados 15 pacientes, 9 do sexo masculino. A idade variou entre 12 e 78 anos. Quatro pacientes tinham diagnóstico de insuficiência aórtica isolada, 2 com dupla disfunção aórtica associada à insuficiência coronária, 2 com doença da aorta ascendente, 4 com insuficiência aórtica e mitral, 1 com dupla disfunção aórtica e mitral, e 2 com insuficiência aórtica e insuficiência coronária. RESULTADOS: Em 12 pacientes não houve insuficiência aórtica residual pós-operatória, e em 3 identificou-se insuficiência aórtica leve ou moderada. Três pacientes foram reoperados no pós-operatório tardio devido a insuficiência aórtica, tendo sido substituída a valva aórtica em 2. Quatro pacientes foram submetidos a estudo hemodinâmico e em 1 deles havia gradiente supravalvar de 20 mmHg. Nos outros 3 pacientes, o gradiente sistólico transvalvar foi de 0, 9 e 12 mmHg, respectivamente. Os 11 pacientes restantes foram avaliados somente através de ecocardiografia, a qual não demonstrou estenose. Não houve óbito imediato e houve 1 óbito tardio, após reoperação. Quatorze pacientes tiveram melhora da classe funcional, tanto imediata quanto tardiamente, e foram acompanhados durante período entre 30 dias e 24 meses, encontrando-se em classe funcional I ou II (NYHA). CONCLUSÃO: Os autores acreditam que o método seja uma alternativa para o tratamento cirúrgico conservador da doença valvar aórtica.<br>PURPOSE: The authors report a method of surgical treatment of the aortic valve disease, called "Surgical Remodeling of Aortic Valve". MATERIAL AND METHOD: The method consisted of the utilization of the habitual extracorporeal circulation, moderated hipothermia and the infusion of cardioplegic solution in the coronary ostia. The non-coronary valvula is resected and stitches anchored in the aortic valva anulus are given in a way to approximate the resected valvula commissures, in order to turn the trivalvular valva into a bivalvulate one. The Valsalva sinus corresponding to the resected valva stays situated below the commissure and the remaining aortic wall is sutured with a few separated stitches, followed with the conventional aortorraphy. Between March of 1996 and July of 1999, 15 patients were operated with the described technique. Nine were male and the age ranged from 12 to 78 years. Four patients had aortic valve insufficiency, 4 with aortic and mitral insufficiency, 2 with double aortic lesion and coronary artery disease, 2 with ascending aortic disease, 2 with aortic insufficiency and coronary artery disease, and 1 with double dysfunction of aortic and mitral valves. RESULTS: Three patients developed aortic insufficiency on the post-operative and 3 of them were operated on in the late post-operative. Four patients were submitted to hemodynamic study and one of them had a supravalvar gradient estimated at 20 mmHg. Eleven patients were studied by echocardiogram and did not have stenosis. There were neither immediate obits and one occurred in the late post-operative period. Fourteen patients were followed during 30 days to 24 months, and had a good evolution (Functional Class I or II of the NYHA). CONCLUSION: This method for the aortic valve preservation is an alternate option for the surgical treatment of the aortic valve disease

TPE magazine international

BACKGROUND: Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted. METHODS/DESIGN: This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution. DISCUSSION: The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil. CLINICAL TRIALS REGISTRATION NUMBER: ClinicalTrials.gov: NCT0097116