Criteria for an informative trial of left ventricular hypertrophy regression. 1994

R B Devereux, and B Dahlof
Department of Medicine, New York Hospital-Cornell Medical Center, NY 10021.

Although many studies have been made of hypertensive left ventricular (LV) hypertrophy regression, most have been marred by small numbers of subjects, unrepresentative populations, short study duration, lack of comparison between agents, unblinded echocardiographic readings and inappropriate statistical methods. Meta-analysis and critical reviews of this flawed literature suggest, but do not prove, that some antihypertensive drug classes may reverse LV hypertrophy more effectively than others. Eagerly awaited multicentre trials have not provided definitive answers because of pre-emptive success of concomitant nonpharmacological therapy in reversing both hypertension and LV hypertrophy or excessive drop-out of study participants. Future studies that avoid the above limitations are needed to address three sets of questions: relatively small ones (n > or = 40 to 60) to investigate pathophysiology in detail or explore the effects of new agents; medium-sized ones (n > or = 300-400, time > or = 1 year) to determine definitively whether inter-agent differences in reduction of LV mass exist; and large long-term trials (n > or = 1200, time > or = 4 years) to determine whether LV hypertrophy reversal improves prognosis over and above blood pressure reduction and the type of treatment used.

UI MeSH Term Description Entries
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015337 Multicenter Studies as Topic Works about controlled studies which are planned and carried out by several cooperating institutions to assess certain variables and outcomes in specific patient populations, for example, a multicenter study of congenital anomalies in children. Multicenter Trials,Multicentre Studies as Topic,Multicentre Trials,Multicenter Trial,Multicentre Trial,Trial, Multicenter,Trial, Multicentre,Trials, Multicenter,Trials, Multicentre
D017379 Hypertrophy, Left Ventricular Enlargement of the LEFT VENTRICLE of the heart. This increase in ventricular mass is attributed to sustained abnormal pressure or volume loads and is a contributor to cardiovascular morbidity and mortality. Left Ventricular Hypertrophy,Ventricular Hypertrophy, Left,Hypertrophies, Left Ventricular,Left Ventricular Hypertrophies,Ventricular Hypertrophies, Left

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