Left atrial remodeling and response to valsartan in the prevention of recurrent atrial fibrillation: the GISSI-AF echocardiographic substudy.

Background: Left atrial (LA) dilation precedes or appears early after the onset of atrial fibrillation (AF) and factors in perpetuating the arrhythmia. Angiotensin receptor blockers were proposed for reversing LA remodeling. We evaluated the effect of valsartan on LA remodeling in patients with a recent episode of AF and the effect of LA size on AF recurrence (AFr).

Clinical, neurohormonal, and inflammatory markers and overall prognostic role of chronic obstructive pulmonary disease in patients with heart failure: data from the Val-HeFT heart failure trial.

Background: Chronic obstructive pulmonary disease (COPD) and heart failure are major causes of death and disability. Because little information is available about the population of patients with both syndromes, we assessed the characteristics and the independent contribution of COPD to outcomes in patients with stable chronic heart failure.

Methods: The clinical, neurohormonal, and echocardiographic characteristics of the 5010 patients enrolled in the Valsartan Heart Failure Trial were compared in patients with or without COPD.

Incremental prognostic value of changes in B-type natriuretic peptide in heart failure.

Purpose: B-type natriuretic peptide is one of the most sensitive and specific biohumoral markers of heart failure. We hypothesized that B-type natriuretic peptide changes during treatment of heart failure may provide independent information on disease progression and outcome in patients enrolled in the Val-HeFT trial.

Methods: Patients were divided into four groups according to concentrations of B-type natriuretic peptide at baseline versus 4 months (n = 3740) or 12 months (n = 3343), with respect to the baseline median (97 pg/mL): low-->low (stable below median, 44%-46%), high-->high (stable above median, 32%-37%), high-->low (above to below median, 12%-14%), and low-->high (below to above median, 6%-9%).

Signs and symptoms in chronic heart failure: relevance of clinical trial results to point of care-data from Val-HeFT.

Background: Clinical trials emphasize mortality and morbidity endpoints.

Aims: To bring relevance of trial results to point of care by examining the prognostic and therapeutic value of individual signs and symptoms (S&S).

Methods: We analysed data from 5010 patients with stable chronic heart failure and left ventricular dysfunction who were participants in the Val-HeFT study.

Severity of left ventricular remodeling defines outcomes and response to therapy in heart failure: Valsartan heart failure trial (Val-HeFT) echocardiographic data.

Objectives: The objective of this study was to test the hypothesis that the severity of left ventricular remodeling predicts the response to treatment and outcomes in chronic heart failure.

Background: Reversal of remodeling should produce the most favorable outcome in patients with the most severe remodeling.

Methods: In 5010 heart failure patients on background therapy and randomized to valsartan and placebo, serial recordings of left ventricular internal diastolic diameter (LVIDd) and ejection fraction (EF) were read at sites that had to meet qualifying standards before participating.

Effect of drug therapy for heart failure on quality of life.

Symptomatic heart failure interferes with a patient's quality of life (QOL) by limiting his or her ability to perform physical tasks and daily activities and by lowering his or her sense of psychological well-being. Therefore, in addition to decreasing mortality and morbidity, improving QOL should be an important goal when selecting pharmacotherapy. QOL questionnaires, both generic and disease specific, are used widely, but in randomized controlled trials of heart failure treatments, QOL has not been a routine study end point.

Valsartan benefits left ventricular structure and function in heart failure: Val-HeFT echocardiographic study.

Objectives: The objective of the study was to evaluate the effect of an angiotensin receptor blocker on left ventricular (LV) structure and function when added to prescribed heart failure therapy.

Background: The clinical benefit derived from heart failure therapy is attributed to the regression of LV remodeling.

Methods: At 302 multinational sites, 5,010 patients in New York Heart Association (NYHA) classification II to IV heart failure taking angiotensin-converting enzyme inhibitor (ACEI) and/or beta-blocker (BB) were randomized into valsartan and placebo groups and followed for a mean of 22.

Quality assessment and quality control of echocardiographic performance in a large multicenter international study: Valsartan in heart failure trial (Val-HeFT).

Objective: To qualify 302 multinational echocardiography sites to record and read serial studies and to monitor quality in 5010 patients randomized into Valsartan in Heart Failure Trial (Val-HeFT).

Background: Decentralized echocardiography reading is unprecedented in large clinical trials.

Methods: Single and duplicate recordings, and triplicate readings of echocardiographic variables were submitted to 3 core laboratories.