Clinical attributes, treatment, and control in hypertension (CATCH)-a French and Italian longitudinal patient database study.

Introduction: Hypertension, a risk factor for cardiovascular disease (CVD), is frequently associated with other CVD risk factors. Despite recent improvement in blood pressure (BP) control in Europe, a substantial proportion of patients fail to achieve BP targets.

Methods: This retrospective cohort study used longitudinal patient databases (LPDs) in France and Italy to examine CVD risk profiles, treatment patterns, and BP goal attainment in hypertensive patients treated in real-world clinical practice between 2007 and 2008.

Acute heart failure in elderly patients: worse outcomes and differential utility of standard prognostic variables. Insights from the PROTECT trial.

Aims: Previous heart failure (HF) trials suggested that age influences patient characteristics and outcome; however, under-representation of elderly patients has limited characterization of this cohort. Whether standard prognostic variables have differential utility in various age groups is unclear.

Methods And Results: The PROTECT trial investigated 2033 patients (median age 72 years) with acute HF randomized to rolofylline or placebo.

Renal function trajectories and clinical outcomes in acute heart failure.

Background: Prior studies have demonstrated adverse risk associated with baseline and worsening renal function in acute heart failure, but none has modeled the trajectories of change in renal function and their impact on outcomes.

Methods And Results: We used linear mixed models of serial measurements of blood urea nitrogen and creatinine to describe trajectories of renal function in 1962 patients with acute heart failure and renal dysfunction enrolled in the Placebo-Controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function study. We assessed risk of 180-day mortality and 60-day cardiovascular or renal readmission and used Cox regression to determine association between renal trajectories and outcomes.

Predictors of postdischarge outcomes from information acquired shortly after admission for acute heart failure: a report from the Placebo-Controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized With Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function (PROTECT) Study.

Background: Acute heart failure is a common reason for admission, and outcome is often poor. Improved prognostic risk stratification may assist in the design of future trials and in patient management. Using data from a large randomized trial, we explored the prognostic value of clinical variables, measured at hospital admission for acute heart failure, to determine whether a few selected variables were inferior to an extended data set.

Assessment of drug-induced increases in blood pressure during drug development: report from the Cardiac Safety Research Consortium.

This White Paper, prepared by members of the Cardiac Safety Research Consortium, discusses several important issues regarding the evaluation of blood pressure (BP) responses to drugs being developed for indications not of a direct cardiovascular (CV) nature. A wide range of drugs are associated with off-target BP increases, and both scientific attention and regulatory attention to this topic are increasing. The article provides a detailed summary of scientific discussions at a Cardiac Safety Research Consortium-sponsored Think Tank held on July 18, 2012, with the intention of moving toward consensus on how to most informatively collect and analyze BP data throughout clinical drug development to prospectively identify unacceptable CV risk and evaluate the benefit-risk relationship.

The predictive value of short-term changes in hemoglobin concentration in patients presenting with acute decompensated heart failure.

Objectives: The study sought to investigate the clinical correlates and prognostic role of anemia and changes in hemoglobin in patients hospitalized for acute decompensated heart failure (AHF).

Background: Anemia is related to a poor outcome in patients with heart failure. In addition, an increase in hemoglobin during hospitalization might be a sign of effective decongestion and therefore related to improved outcome.

The PROTECT in-hospital risk model: 7-day outcome in patients hospitalized with acute heart failure and renal dysfunction.

Aims: In patients with acute heart failure (AHF), early worsening heart failure (WHF) predicts a significant proportion of post-discharge readmissions and mortality. We aimed to identify the predictors of 7-day heart failure events or death in patients hospitalized with AHF.

Methods And Results: A predictive model and risk score for the short-term primary composite endpoint of 7-day death, HF rehospitalization, or WHF was created using variables collected within 24 h of admission from patients with complete data (n = 2015) enrolled in the PROTECT trial of AHF patients.

The safety of an adenosine A(1)-receptor antagonist, rolofylline, in patients with acute heart failure and renal impairment: findings from PROTECT.

Background: Adenosine exerts actions in multiple organ systems, and adenosine receptors are a therapeutic target in many development programmes.

Objective: The aim of this analysis was to evaluate the safety of rolofylline, an adenosine A(1)-receptor antagonist, in patients with acute heart failure.

Methods: The effect of rolofylline was investigated in patients hospitalized for acute heart failure with impaired renal function.

Impact of serial troponin release on outcomes in patients with acute heart failure: analysis from the PROTECT pilot study.

Background: Cardiac troponin T (cTnT) elevation is common and is a predictor of outcomes in patients with acute heart failure (AHF). The degree and progression of cTnT release during hospitalization of patients with AHF is unclear. We evaluated the incidence of cTnT release during AHF hospitalization and the relationship of cTnT release with outcomes.

Effects of the adenosine A1 receptor antagonist rolofylline on renal function in patients with acute heart failure and renal dysfunction: results from PROTECT (Placebo-Controlled Randomized Study of the Selective Adenosine A1 Receptor Antagonist Rolofylline for Patients Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function).

Objectives: This study sought to assess the effects of rolofylline on renal function in patients with acute heart failure (AHF) and renal dysfunction randomized in PROTECT (Placebo-Controlled Randomized Study of the Selective A(1) Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized With Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function).

Background: Small studies have indicated that adenosine A(1) receptor antagonists enhance diuresis and may improve renal function in patients with chronic heart failure or AHF.

Methods: A total of 2,033 patients with AHF, volume overload, estimated creatinine clearance between 20 and 80 ml/min, and elevated natriuretic peptide levels were randomized (2:1) within 24 h of hospital presentation to rolofylline 30 mg/day or intravenous placebo for up to 3 days.

Early dyspnoea relief in acute heart failure: prevalence, association with mortality, and effect of rolofylline in the PROTECT Study.

Aims: Dyspnoea and pulmonary and/or peripheral congestion are the most frequent manifestations of acute heart failure (AHF) and are important targets for therapy. We have assessed changes in dyspnoea, their relationship with mortality, and the effects of the adenosine A1 receptor antagonist rolofylline on these endpoints in patients enrolled in the PROTECT trial.

Methods And Results: PROTECT was a prospective, double-blind, placebo-controlled study assessing the effect of rolofylline in patients hospitalized for AHF with dyspnoea, fluid overload, increased plasma natriuretic peptides, and mild-to-moderate renal dysfunction.

Rolofylline, an adenosine A1-receptor antagonist, in acute heart failure.

Background: Worsening renal function, which is associated with adverse outcomes, often develops in patients with acute heart failure. Experimental and clinical studies suggest that counterregulatory responses mediated by adenosine may be involved. We tested the hypothesis that the use of rolofylline, an adenosine A1-receptor antagonist, would improve dyspnea, reduce the risk of worsening renal function, and lead to a more favorable clinical course in patients with acute heart failure.

Design and rationale of the PROTECT study: a placebo-controlled randomized study of the selective A1 adenosine receptor antagonist rolofylline for patients hospitalized with acute decompensated heart failure and volume overload to assess treatment effect on congestion and renal function.

Background: Current treatment for acute decompensated heart failure (ADHF) is associated with incomplete resolution of symptoms and signs, recurrent symptoms of heart failure in-hospital and after discharge and high mortality. Studies have consistently demonstrated an association between worsening renal function in ADHF and adverse outcomes. Adenosine A(1) receptor antagonists, such as rolofylline, appear in preliminary studies to produce potentially beneficial effects on natriuresis, diuresis, renal blood flow, and glomerular filtration rate.

The importance of the clinical observer in the development of a white-coat effect in African-American patients with hypertension.

Introduction: As the office-awake blood pressure (BP) difference (white-coat effect) in African-Americans has not been evaluated, we studied the ethnicity, professional status (nurse versus doctor) and sex of the observer on the white-coat effect in African-American patients with hypertension.

Methods: Seated clinical BP measurements were obtained in random order by an African-American male research physician, a Caucasian male research physician, and a Caucasian female nurse who is of similar age and clinical experience. Within 1 week, ambulatory BP recordings were performed.

Endothelial dysfunction and history of recurrent depression in postmenopausal women with Type 2 diabetes: a case-control study.

Objectives: This study of postmenopausal women with Type 2 diabetes mellitus (T2DM) investigated (1) history of depression as a predictor of endothelium-dependent flow-mediated dilation (FMD); (2) the relative associations of single and recurrent depressive disorders with FMD; and (3) cortisol as a potential mechanism.

Methods: Participants were nonsmoking, naturally postmenopausal women with T2DM with no known vascular disease. All were free of current mood disorder.

Primary hyperaldosteronism associated with hypertensive emergencies.

There is growing awareness of primary hyperaldosteronism as a cause of secondary hypertension. Usually, it manifests as hypertension and hypokalemia, or as resistant hypertension. Much less often, primary hyperaldosteronism may be detected after a hypertensive emergency has developed.

Orthostatic hypotension due to autonomic disorders in the hypertension clinic.

Hypertension specialists are consulted regarding orthostatic hypotension (OH) or the combination of OH with supine hypertension. These clinical presentations are often associated with a variety of underlying autonomic disorders. A comprehensive medical history and clinical examination with attention to autonomic signs and the neurological system may suggest the possible etiology or a differential diagnosis.

History of major depressive disorder and endothelial function in postmenopausal women.

Objective: To determine whether history of depression is associated with endothelium-dependent flow-mediated dilation (FMD) in postmenopausal women.

Methods: Thirty-nine postmenopausal women with no known or suspected cardiovascular disease participated. Nineteen had a positive lifetime history of major depressive disorder, and 20 were never depressed.

Herbs and alternative therapies: relevance to hypertension and cardiovascular diseases.

Herbal remedies, supplements, and alternative therapeutic items are used by many patients with hypertension and cardiovascular diseases. Scientific knowledge about their efficacy and safety is lacking, and unfortunately, physicians are frequently not aware that patients are using these nontraditional forms of medical care. Patients may anticipate physicians' disapproval of their use, or not realize that it is important for the physician to know what they are taking.

Self-measured home blood pressure in predicting ambulatory hypertension.

Background: Physicians are commonly uncertain whether a person with office blood pressure (BP) around 140/90 mm Hg actually has hypertension. This is primarily because of BP variability. One approach is to perform self-measured home BP and determine if home BP is elevated.

Effect of spironolactone on endothelial function in patients with congestive heart failure on conventional medical therapy.

We prospectively studied the effect of spironolactone, an aldosterone antagonist, on endothelial function in patients with advanced congestive heart failure (CHF) using the brachial artery reactivity method. Twenty patients optimized on conventional CHF therapy were treated with spironolactone, and brachial artery flow- mediated dilation was measured at baseline and at 4 and 8 weeks. Spironolactone improved endothelial function at 4 weeks, and sustained the improvement at 8 weeks, in patients with CHF on conventional medical therapy, presumably due to reversal of aldosterone impairment of endothelial nitric oxide activity.

The use of peridialysis blood pressure and intradialytic blood pressure changes in the prediction of interdialytic blood pressure in haemodialysis patients.

Objective: It is uncertain which blood pressure values (pre- or post-haemodialysis) best represent the average daily blood pressure in haemodialysis patients. The purpose of this study was to verify the power of peridialysis blood pressure to predict interdialytic blood pressure, and to ascertain the influence of blood pressure fluctuations during dialysis on this predictive ability.

Methods And Results: We performed ambulatory blood pressure monitoring during the interdialytic period on 60 stable haemodialysis patients (mean age 53 +/- 16 years, 33 male) between two mid-week haemodialysis sessions.

Blood pressure control in the hypertension clinic.

Background: One effort to improve hypertension care in the United States is the development of the "Hypertension Specialist" program with appropriate training and certification of individual physicians.

Methods: We examined the impact of a hypertension clinic on blood pressure (BP) levels and control.

Results: By one year, BP declined 18/9 mm Hg, (P =.

A practical approach to persistent elevation of blood pressure in the hypertension clinic.

Patients seen with persistent elevation of office blood pressure (BP) in the hypertension clinic are common and pose a significant challenge to the hypertension specialist. These are usually patients sent to the clinic because of difficulty in achieving BP goals. In this clinical setting there is usually data available from home self measurement and ambulatory BP readings.