Lead Investigator: Leire Leache, Navarre Health Service
Title of Proposal Research: Cochrane Systematic Review – Pharmacotherapy for hypertension induced left ventricular hypertrophy
Vivli Data Request: 6515
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Abnormally high blood pressure is one of the most important contributors to heart disease and stroke, which together are one of the leading causes of premature morbidity and mortality. Estimates of the overall prevalence of high blood pressure in adults are greatly influenced by the cutpoint established to categorize it, varying from 30% to 46%.
One of the clinical effects of high blood pressure is left ventricular hypertrophy (LVH), which describes the changes in the heart ventricular muscle in response to increased demand for energy. These changes are called cardiac remodeling which, in addition to achieving greater functionality, can also lead to heart disease. LVH prevalence in people with high blood pressure varies between 36% according to more restrictive diagnostic criteria and 41% according to less conservative ones.
LVH is considered to be the most potent predictor of morbidity and overall mortality in the population with high blood pressure, and an independent risk factor for coronary heart disease, sudden death, heart failure, irregular and often fast heart, and stroke. Severity of the LVH is in turn associated to a higher prevalence of diseases affecting the heart or blood vessels. Mortality of individuals with LVH is three to four times higher than of those without LVH. Prevention or regression of left ventricular geometric changes with blood pressure control is an effective way of decreasing future adverse cardiovascular events in patients with high blood pressure. Indeed, current guidelines recommend treating patients with high blood pressure and LVH with antihypertensives.
Reviews comparing different antihypertensive drug classes in LVH regression are inconsistent and they do not analyze the repercussion on cardiovascular events or mortality. A systematic review published in 2010 found that regression of LVH diagnosed by ultrasound scan of the heart was associated with reduction of cardiovascular events. However, since then management of LVH has changed and to date, no systematic review assessing the effect of antihypertensive drug therapy in LVH induced by high blood pressure has been undertaken using the methodology used in the systematic reviews recognized as the highest evidence-based standard in health care. Therefore, this research will provide updated evidence to improve clinical management of people with high blood pressure and LVH.
The aim of the study is to carry out a systematic review to analyze the effect of antihypertensive drug therapy on adults with LVH induced by high blood pressure. Antihypertensive pharmacological therapy either in monotherapy or in combination (intervention) will be compared with placebo or no treatment.
Primary outcomes are the following: all-cause mortality, cardiovascular events and total serious adverse events. Secondary outcomes are: hospitalization for heart failure, reduction in the index of left ventricular mass, total adverse events and withdrawal due to adverse events.
Randomized controlled trials with at least 12 months’ follow-up that analyse at least one primary outcome will be included in the review.
Data will be analyzed using the methodology used in the systematic reviews recognized as the highest evidence-based standard in health care. Meta-analyses will be carried out to analyze data obtained from the identified studies. Risk if bias of the included studies and quality of the evidence will be assessed. Additionaly, several sensitivity analyses will be carried out to test the robustness of the results, as well as subgroup analyses in case of heterogeneity.
PRoFESS – Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
Sponsor: Boehringer Ingelheim
Study ID: NCT00153062
Sponsor ID: 9.159
ONTARGET ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial A Large, Simple Randomized Trial of an Angiotensin II Receptor Antagonist (Telmisartan) and an ACE-Inhibitor (Ramipril) in Patients at High Risk for Cardiovascular Events and TRANSCEND Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects With Cardiovascular Disease. A Parallel Study Comparing the Effects of Telmisartan With Placebo and Outcomes in Patients at High Risk for Cardiovascular Events and Intolerant to ACE-I.
Sponsor: Boehringer Ingelheim
Study ID: NCT00153101
Sponsor ID: 502.373