Conivaptan: New treatment for hyponatremia

2007 ◽  
Vol 64 (13) ◽  
pp. 1385-1395 ◽  
Author(s):  
Kimberly A. Walter
Keyword(s):  
Heart Failure ◽  
Acute Decompensated Heart Failure ◽  
Free Water ◽  
Decompensated Heart Failure ◽  
The United States ◽  
Multicenter Studies ◽  
Double Blind ◽  
Water Excretion ◽  
Safety Issues ◽  
Dosing Regimens

Abstract Purpose. The pharmacology, bioavailability and pharmacokinetics, clinical efficacy, adverse effects and toxicities, drug interactions, dosage and administration, and safety issues related to the use of conivaptan are discussed. Summary. Conivaptan hydrochloride is a nonpeptide, V1A and V2 vasopressin-receptor antagonist. It is available as an i.v. formulation in 4-mL ampules containing 20 mg of conivaptan hydrochloride. The drug is active both orally and i.v. Conivaptan injection is approved for the treatment of euvolemic hyponatremia in hospitalized patients. Three double-blind, placebo-controlled, randomized, multicenter studies have been conducted in the United States and internationally. The studies used various dosing regimens for conivaptan but maintained the same efficacy endpoints. Each study showed conivaptan to be effective in increasing serum sodium and in water clearance. Conivaptan is being evaluated in the treatment of acute decompensated heart failure and chronic heart failure, but the safety of this drug has not been fully established. The drug has been generally well tolerated in clinical trials with both oral and i.v. administration. The approved dosing regimen consists of a 20-mg i.v. loading dose administered over 30 minutes, followed by a continuous infusion of 20 mg administered over 24 hours. Clinical studies evaluating conivaptan have been short term; longer-term effects of hemodynamic parameters are unknown. Conclusion. Conivaptan, the first vasopressin antagonist approved for the treatment of euvolemic hyponatremia, has a unique mechanism of action that results in free-water excretion and offers a new option for the treatment of resistant hyponatremia in the acute setting when patients have not responded to standard management.

1135Angiotensin receptor-neprilysin inhibition in patients with de novo acute decompensated heart failure: a prespecified subgroup analysis of the PIONEER-HF trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Ambrosy ◽  
E Braunwald ◽  
D Morrow ◽  
A Devore ◽  
K McCague ◽  
...  
Keyword(s):  
Heart Failure ◽  
De Novo ◽  
Acute Decompensated Heart Failure ◽  
Decompensated Heart Failure ◽  
The United States ◽  
Cardiovascular Death ◽  
P Value ◽  
Double Blind ◽  
Neprilysin Inhibitor ◽  
History Of

Abstract Background The efficacy, safety, and tolerability of an angiotensin receptor-neprilysin inhibitor (ARNi) in patients presenting with de novo heart failure (HF) has not been previously well-defined. Methods The PIONEER-HF trial was a prospective, multicenter, double-blind, active-controlled, randomized clinical trial which enrolled 887 patients (pts) at 129 sites in the United States. Pts with or without a history of prior HF and an ejection fraction (EF) <40% and a NT-proBNP >1600 pg/mL or BNP >400 pg/mL were eligible for participation no earlier than 24 hours while still hospitalized for acute decompensated HF (ADHF). Pts were randomly assigned 1:1 to in-hospital initiation of sacubitril/valsartan (S/V) titrated to 97/103 mg vs. enalapril titrated to 10 mg both by mouth twice daily for 8 weeks. We performed a pre-specified analysis in pts with de novo HF (i.e., defined as pts without a history of HF prior to the qualifying ADHF event). Results At the time of enrollment, 34% (N=303) had de novo HF. These pts experienced a similar improvement in NT-proBNP with S/V vs. enalapril (Ratio of geometric means 0.65, 95% Confidence Interval [CI] 0.53–0.81; p-value = 0.0002) compared to pts with worsening chronic HF (ratio 0.72 (0.63–0.83, p-value <0.0001) (Figure). In addition, the incidence of worsening renal function, hyperkalemia, and hypotension was comparable with S/V vs. enalapril regardless of whether they were hospitalized for de novo or worsening chronic HF. Finally, there was no interaction (p-value = 0.350) between previous HF status and the effect of S/V on the composite of cardiovascular death or rehospitalization for HF (de novo HF: Hazard Ratio [HR] 0.34, 95% CI 0.11–1.05 vs. worsening chronic HF: HR 0.60, 95% CI 0.39–0.93). Conclusion Among patients admitted for ADHF, irrespective of prior HF history, in-hospital initiation of an ARNi led to a greater reduction in natriuretic peptide levels, a comparable safety profile, and a significant improvement in clinical outcomes. Acknowledgement/Funding Novartis

scholarly journals Hyponatremia and Congestive Heart Failure: A Marker of Increased Mortality and a Target for Therapy

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Adam Romanovsky ◽  
Sean Bagshaw ◽  
Mitchell H. Rosner
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Free Water ◽  
Volume Overload ◽  
Decompensated Heart Failure ◽  
Vasopressin Receptor ◽  
Receptor Antagonists ◽  
Water Excretion ◽  
Multiple Systems ◽  
Developed World

Heart failure is one of the most common chronic medical conditions in the developed world. It is characterized by neurohormonal activation of multiple systems that can lead to clinical deterioration and significant morbidity and mortality. In this regard, hyponatremia is due to inappropriate and continued vasopressin activity despite hypoosmolality and volume overload. Hyponatremia is also due to diuretic use in an attempt to manage volume overload. When hyponatremia occurs, it is a marker of heart failure severity and identifies patients with increased mortality. The recent introduction of specific vasopressin-receptor antagonists offers a targeted pharmacological approach to these pathophysiological derangements. Thus far, clinical trials with vasopressin-receptor antagonists have demonstrated an increase in free-water excretion, improvement in serum sodium, modest improvements in dyspnea but no improvement in mortality. Continued clinical trials with these agents are needed to determine their specific role in the treatment of both chronic and decompensated heart failure.

Remote TELEmonitoring and Health Coaching for patients with acute heart failure: results of the TELE-HC randomized trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Schulte ◽  
L Olson ◽  
C Bruce
Keyword(s):  
Heart Failure ◽  
Randomized Trial ◽  
Standard Care ◽  
Primary Outcome ◽  
Acute Decompensated Heart Failure ◽  
Treatment Strategies ◽  
Decompensated Heart Failure ◽  
The United States ◽  
Health Coaching ◽  
Funding Source

Abstract Introduction Patients discharged after acute decompensated heart failure (ADHF) have elevated risk for readmission due to multiple factors including suboptimal behavioral and social support. Telemonitoring interventions have shown inconsistent effectiveness in reducing HF readmissions. Patient-centered health coaching, when combined with telemonitoring, may be a viable model to engage patients in self-care behaviors and enhance patient experiences following acute hospitalization. Purpose This multicenter randomized trial evaluates whether remote telemonitoring combined with health coaching decreases 60 day readmission rates for patients with ADHF when compared to standard of care. Methods Patients with primary or secondary diagnosis of ADHF were consented and randomized prior to hospital discharge to either standard care or intervention of remote telemonitoring and health coaching. Within 2 days of hospital dismissal, intervention patients were onboarded to the remote monitoring platform, which links personal health sensors which collect on-body physiologic measures (ECG, heart rate, respiration rate, and activity via 3-axis accelerometer) with providers through secure mobile communication. A registered nurse was designated as the primary health coach focusing on disease management - including symptom recognition, adherence to treatment strategies, care coordination, medication matters, and problem solving. A social worker and nutritionist were also assigned. The primary outcome was all-cause mortality or readmission within 60 days of hospital dismissal. Statistical analysis included stratified log-rank tests and stratified Cochran-Mantel-Haenszel Chi-square test to account for site-stratified randomization. Results The study was halted due to low rate of subject accrual. Of planned 304 subjects, 143 were randomized between 2015 and 2019 at 6 sites in the United States. Dropout and withdrawal after randomization of 32 subjects (22%) left 112 analyzable for the primary endpoint. Many subject withdrawals after unblinded disclosure of arm allocation were related to treatment assignment. Immediate withdrawal without follow up in these subjects precluded an intention-to-treat analysis. Mean age was 69 years and subjects were more often male (56%) and non-Hispanic white (70%). In per-protocol analysis, using subjects adherent to protocol specified visits (n=112), we observe no difference in the primary outcome (26% among intervention vs 28% among standard care, Figure, p=0.77). There were also no differences among secondary outcomes of overall mortality (2% vs 7%, p=0.20) or composite emergency department visit, hospital admission, or death (35% vs 34%, p=0.85). Conclusions Among patients with heart failure, an intervention of remote telemonitoring and health coaching did not reduce all-cause readmission or mortality. Significant withdrawal rates suggest future studies may need to improve screening and study retention. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health, National Institute on Aging

scholarly journals Comparison of management and outcomes of ED patients with acute decompensated heart failure between the Canadian and United States’ settings

CJEM ◽  
2015 ◽  
Vol 18 (2) ◽  
pp. 81-89 ◽  
Author(s):  
Anita Lai ◽  
Elliott Tenpenny ◽  
David Nestler ◽  
Erik Hess ◽  
Ian G. Stiell
Keyword(s):  
United States ◽  
Heart Failure ◽  
Acute Decompensated Heart Failure ◽  
Admission Rate ◽  
Decompensated Heart Failure ◽  
The United States ◽  
Health Records ◽  
Male Sex ◽  
Relapse Rates ◽  
The U.S

AbstractIntroductionThe objective of this study was to compare the emergency department (ED) management and rate of admission of acute decompensated heart failure (ADHF) between two hospitals in Canada and the United States and to compare the outcomes of these patients.MethodsThis was a health records review of adults presenting with ADHF to two EDs in Canada and the United States between January 1 and April 30, 2010. Outcome measures were admission to the hospital, myocardial infarction (MI), and death or relapse rates to the ED. Data were analysed using descriptive, univariate and multivariate analyses.ResultsIn total, 394 cases were reviewed and 73 were excluded. Comparing 156 Canadian to 165 U.S. patients, respectively, mean age was 76.0 and 75.8 years; male sex was 54.5% and 52.1%. Canadian and U.S. ED treatments were noninvasive ventilation 7.7% v. 12.8% (p=0.13); IV diuretics 77.6% v. 36.0% (p<0.001); IV nitrates 4.5% v. 6.7% (p=0.39). There were significant differences in rate of admission (50.6% v. 95.2%, p<0.001) and length of stay in ED (6.7 v. 3.0 hours, p<0.001). Proportion of Canadian and U.S. patients who died within 30 days of the ED visit was 5.1% v. 9.7% (p=0.12); relapsed to the ED within 30 days was 20.8% v. 17.5% (p=0.5); and had MI within 30 days was 2.0% v. 1.9% (p=1.0).ConclusionsThe U.S. and Canadian centres saw ADHF patients with similar characteristics. Although the U.S. site had almost double the admission rate, the outcomes were similar between the sites, which question the necessity of routine admission for patients with ADHF.

Abstract 206: An Obesity Paradox in Acute Decompensated Heart Failure

2014 ◽  
Vol 34 (suppl_1) ◽  
Author(s):  
Mahdi Khoshchehreh ◽  
Shaista Malik
Keyword(s):  
Heart Failure ◽  
Hospital Mortality ◽  
Acute Decompensated Heart Failure ◽  
Decompensated Heart Failure ◽  
Obesity Paradox ◽  
The United States ◽  
Hospitalized Patients ◽  
Hospital Death ◽  
Morbidly Obese ◽  
Obese Patients

Background: Prior studies on heart failure (HF) have shown that body mass index (BMI) is inversely associated with mortality. The aim of this study was to investigate the impact of morbid obesity (BMI > 40 kg/m2) on in-hospital mortality in patients presenting with Acute decompensated heart failure (ADHF). Methods: The Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project was analyzed for acute HF hospitalizations across the United States. A total number of 966,167 hospitalized patients with ADHF in 2009 were reviewed. Results: Morbidly obese patients constituted 13.4% of all patients with ADHF. Analysis of the unadjusted data revealed that morbidly obese patients compared with those not morbidly obese were less likely to die during hospitalization (OR 0.55, %95CI 0.53-0.57, P<0.0001). Cox proportional hazards regression was used to estimate the overall probability of in-hospital death with adjustments for age, sex, race, Elixhauser comorbidities, primary payer, hospital location, hospital teaching status, hospital bed-size, and total hospital admissions. The adjusted hazard of in-hospital death (HR 0.87, p< <.0001) indicates that there was statistically significant difference in the risk of in-hospital death associated with being morbidly obese. Conclusions: In this cohort of hospitalized patients with ADHF, higher BMI was associated with lower in-hospital mortality risk. The relationship between BMI and adverse outcomes in HF appears to be complex and consistent with the phenomenon of the “obesity paradox.”

An academic medical centre's programme to develop clinical pathways to manage health care: focus on acute decompensated heart failure

2008 ◽  
Vol 12 (2) ◽  
pp. 45-55 ◽  
Author(s):  
Dawn Lombardo ◽  
Tania V Bridgeman ◽  
Nathalie De Michelis ◽  
Molly Nunez
Keyword(s):  
Heart Failure ◽  
Health Care ◽  
Clinical Pathway ◽  
Care Delivery ◽  
Acute Decompensated Heart Failure ◽  
Clinical Pathways ◽  
Medical Center ◽  
Decompensated Heart Failure ◽  
The United States ◽  
Public Health Issue

Heart failure (HF) is a major public health issue and acute decompensated heart failure (ADHF) is a leading cause of hospitalization in the USA. The United States health care delivery system is bound by regulatory agencies requiring strict compliance to key clinical indicators, which are publicly reported. Clinical pathway development is a systematic approach to managing health care that involves a high degree of collaboration between patients, physicians, nurses and various health-care team professionals. The University of California, Irvine Medical Center (UCIMC) developed an evidence-based multidisciplinary pathway for patients with ADHF. This clinical pathway incorporates universally proven assessment and treatment measures in ADHF. Adjunctive to this process are patient and nursing guides to the ADHF pathway. Utilization of this pathway has been shown to significantly impact clinical performance by early identification of potential negative clinical outcomes. Clinical pathways, such as the ADHF pathway, promote clinical excellence in caring for acute and chronic diseases states.

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