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  1. Article ; Online: Serelaxin in clinical development: past, present and future.

    Unemori, Elaine

    British journal of pharmacology

    2017  Volume 174, Issue 10, Page(s) 921–932

    Abstract: The availability of highly purified recombinant human relaxin, serelaxin, has allowed clinical trials to be conducted in several indications and the elucidation of its pharmacology in human subjects. These studies have demonstrated that serelaxin has ... ...

    Abstract The availability of highly purified recombinant human relaxin, serelaxin, has allowed clinical trials to be conducted in several indications and the elucidation of its pharmacology in human subjects. These studies have demonstrated that serelaxin has unique haemodynamic properties that are likely to contribute to organ protection and long-term outcome benefits in acute heart failure. Clinical observations support its consideration for therapeutic use in other patient populations, including those with chronic heart failure, coronary artery disease, portal hypertension and acute renal failure.
    Linked articles: This article is part of a themed section on Recent Progress in the Understanding of Relaxin Family Peptides and their Receptors. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v174.10/issuetoc.
    MeSH term(s) Clinical Trials as Topic ; Heart Failure/drug therapy ; Heart Failure/metabolism ; Humans ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/chemistry ; Recombinant Proteins/pharmacology ; Recombinant Proteins/therapeutic use ; Relaxin/administration & dosage ; Relaxin/chemistry ; Relaxin/pharmacology ; Relaxin/therapeutic use
    Chemical Substances Recombinant Proteins ; serelaxin protein, human ; Relaxin (9002-69-1)
    Language English
    Publishing date 2017-01-29
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 80081-8
    ISSN 1476-5381 ; 0007-1188
    ISSN (online) 1476-5381
    ISSN 0007-1188
    DOI 10.1111/bph.13695
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  2. Article ; Online: Peptide hormone relaxin: from bench to bedside.

    Jelinic, Maria / Marshall, Sarah A / Stewart, Dennis / Unemori, Elaine / Parry, Laura J / Leo, Chen Huei

    American journal of physiology. Regulatory, integrative and comparative physiology

    2018  Volume 314, Issue 6, Page(s) R753–R760

    Abstract: The peptide hormone relaxin has numerous roles both within and independent of pregnancy and is often thought of as a "pleiotropic hormone." Relaxin targets several tissues throughout the body, and has many functions associated with extracellular matrix ... ...

    Abstract The peptide hormone relaxin has numerous roles both within and independent of pregnancy and is often thought of as a "pleiotropic hormone." Relaxin targets several tissues throughout the body, and has many functions associated with extracellular matrix remodeling and the vasculature. This review considers the potential therapeutic applications of relaxin in cervical ripening, in vitro fertilization, preeclampsia, acute heart failure, ischemia-reperfusion, and cirrhosis. We first outline the animal models used in preclinical studies to progress relaxin into clinical trials and then discuss the findings from these studies. In many cases, the positive outcomes from preclinical animal studies were not replicated in human clinical trials. Therefore, the focus of this review is to evaluate the various animal models used to develop relaxin as a potential therapeutic and consider the limitations that must be addressed in future studies. These include the use of human relaxin in animals, duration of relaxin treatment, and the appropriateness of the clinical conditions being considered for relaxin therapy.
    MeSH term(s) Animals ; Disease Models, Animal ; Female ; Heart Failure/drug therapy ; Humans ; Liver Diseases/drug therapy ; Pregnancy ; Relaxin/pharmacology ; Relaxin/physiology ; Relaxin/therapeutic use ; Reperfusion Injury/drug therapy
    Chemical Substances Relaxin (9002-69-1)
    Language English
    Publishing date 2018-02-07
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 603839-6
    ISSN 1522-1490 ; 0363-6119
    ISSN (online) 1522-1490
    ISSN 0363-6119
    DOI 10.1152/ajpregu.00276.2017
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  3. Article ; Online: Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour.

    Weiss, Gerson / Teichman, Sam / Stewart, Dennis / Nader, David / Wood, Susan / Breining, Peter / Unemori, Elaine

    BMC pregnancy and childbirth

    2016  Volume 16, Page(s) 260

    Abstract: Background: Nonclinical studies indicate that the hormone relaxin is a good candidate for a safe cervical ripening agent that does not cause uterine contractions.: Methods: This Phase II study (conducted November 2, 2005-October 20, 2006) was a ... ...

    Abstract Background: Nonclinical studies indicate that the hormone relaxin is a good candidate for a safe cervical ripening agent that does not cause uterine contractions.
    Methods: This Phase II study (conducted November 2, 2005-October 20, 2006) was a randomised, double blind, placebo controlled trial testing 24-h intravenous infusion of serelaxin (recombinant human relaxin) or placebo for cervical ripening in 72 healthy, primiparous women. Eligible subjects had a singleton pregnancy ≥40 weeks, were planned for elective induction, had vertex presentation of the fetus, intact membranes and a Bishop score at screening ≤4. In Part A of the study, safety evaluation of three escalating doses of serelaxin (7.5, 25 or 75 μg/kg/day) or placebo was performed in 22 subjects admitted to the hospital 24 h prior to scheduled induction (n = 7, 4, 4, and 7 subjects, respectively). The highest safe dose from Part A and placebo were then tested in Part B for safety and cervical ripening (n = 25 subjects/arm). Planned randomisation ratio was of 4:2 (serelaxin:placebo) for each dose group in Part A and 1:1 for Part B. For analysis, subjects in Part B were pooled with those receiving the same dose in Part A and all subjects receiving placebo were pooled. The primary efficacy endpoint was change from baseline in Bishop score at 6, 12 and 24 h or end of study drug administration. Maternal safety evaluations included adverse events and vital signs through 4 weeks. Fetal assessments included serial heart rate monitoring and nonstress testing. Neonatal assessments included Apgar scores, NICU admissions, and adverse events through 4 weeks.
    Results: Overall, 74 subjects were randomized and 72 were treated. There were no significant differences between the groups receiving the highest safe dose of serelaxin (75 μg/kg/day) and placebo in the primary or secondary efficacy endpoints. Changes from baseline in Bishop score at 24 h were 4.19 ± 1.9 and 3.26 ± 2.26 in the pooled placebo and serelaxin groups, respectively (p = 0.2507). Serelaxin was well tolerated and no anti-serelaxin antibodies were detected in either subjects or neonates.
    Conclusion: Serelaxin infusion at the end of pregnancy was well tolerated but did not advance cervical ripening.
    Trial registration: Clinicaltrials.gov identifier NCT00259103 (15 November 2005).
    Language English
    Publishing date 2016-09-05
    Publishing country England
    Document type Journal Article
    ISSN 1471-2393
    ISSN (online) 1471-2393
    DOI 10.1186/s12884-016-1046-1
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  4. Article ; Online: Relaxin deficiency results in increased expression of angiogenesis- and remodelling-related genes in the uterus of early pregnant mice but does not affect endometrial angiogenesis prior to implantation.

    Marshall, Sarah A / Ng, Leelee / Unemori, Elaine N / Girling, Jane E / Parry, Laura J

    Reproductive biology and endocrinology : RB&E

    2016  Volume 14, Page(s) 11

    Abstract: Background: Extensive uterine adaptations, including angiogenesis, occur prior to implantation in early pregnancy and are potentially regulated by the peptide hormone relaxin. This was investigated in two studies. First, we took a microarray approach ... ...

    Abstract Background: Extensive uterine adaptations, including angiogenesis, occur prior to implantation in early pregnancy and are potentially regulated by the peptide hormone relaxin. This was investigated in two studies. First, we took a microarray approach using human endometrial stromal (HES) cells treated with relaxin in vitro to screen for target genes. Then we aimed to investigate whether or not relaxin deficiency in mice affected uterine expression of representative genes associated with angiogenesis and uterine remodeling, and also blood vessel proliferation in the pre-implantation mouse endometrium.
    Methods: Normal HES cells were isolated and treated with recombinant human relaxin (10 ng/ml) for 24 h before microarray analysis. Reverse transcriptase PCR was used to analyze gene expression of relaxin and its receptor (Rxfp1) in ovaries and uteri; quantitative PCR was used to analyze steroid receptor, angiogenesis and extracellular matrix remodeling genes in the uteri of wild type (Rln+/+) and Rln-/- mice on days 1-4 of pregnancy. Immunohistochemistry localized endometrial endothelial cell proliferation and mass spectrometry measured steroid hormones in the plasma.
    Results: Microarray analysis identified 63 well-characterized genes that were differentially regulated in HES cells after relaxin treatment. Expression of some of these genes was increased in the uterus of Rln+/+ mice by day 4 of pregnancy. There was significantly higher vascular endothelial growth factor A (VegfA), estrogen receptor 1 (Esr1), progesterone receptor (Pgr), Rxfp1, egl-9 family hypoxia-inducible factor 1 (Egln1), hypoxia inducible factor 1 alpha (Hif1α), matrix metalloproteinase 14 (Mmp14) and ankryn repeat domain 37 (Ankrd37) in Rln-/- compared to Rln+/+ mice on day 1. Progesterone receptor expression and plasma progesterone levels were higher in Rln-/- mice compared to Rln+/+ mice. However, endometrial angiogenesis was not advanced as pre-implantation endothelial cell proliferation did not differ between genotypes.
    Conclusions: Relaxin treatment modulates expression of a variety of angiogenesis-related genes in HES cells. However, despite accelerated uterine gene expression of steroid receptor, progesterone and angiogenesis and extracellular matrix remodeling genes in Rln-/- mice, there was no impact on angiogenesis. We conclude that although relaxin deficiency results in phenotypic changes in the pre-implantation uterus, endogenous relaxin does not play a major role in pre-implantation angiogenesis in the mouse uterus.
    MeSH term(s) Animals ; Cell Proliferation ; Endometrium/cytology ; Endometrium/metabolism ; Female ; Gene Expression/drug effects ; Gene Expression Profiling ; Humans ; Immunohistochemistry ; Mass Spectrometry ; Mice ; Mice, Inbred C57BL ; Neovascularization, Physiologic/genetics ; Neovascularization, Physiologic/physiology ; Oligonucleotide Array Sequence Analysis ; Pregnancy ; Relaxin/pharmacology ; Relaxin/physiology ; Stromal Cells ; Uterus/cytology ; Uterus/metabolism
    Chemical Substances Relaxin (9002-69-1)
    Language English
    Publishing date 2016-03-22
    Publishing country England
    Document type Journal Article
    ISSN 1477-7827
    ISSN (online) 1477-7827
    DOI 10.1186/s12958-016-0148-y
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  5. Article ; Online: Scientific rationale and design of a phase I safety study of relaxin in women with severe preeclampsia.

    Unemori, Elaine / Sibai, Baha / Teichman, Sam L

    Annals of the New York Academy of Sciences

    2009  Volume 1160, Page(s) 381–384

    Abstract: The pathophysiology of preeclampsia involves profound systemic vasoconstriction. Its etiology may be related to reduced blood flow to the placenta, leading to the elaboration of soluble, vasoactive factors which increase maternal systemic vascular ... ...

    Abstract The pathophysiology of preeclampsia involves profound systemic vasoconstriction. Its etiology may be related to reduced blood flow to the placenta, leading to the elaboration of soluble, vasoactive factors which increase maternal systemic vascular resistance and cause renal dysfunction. Reduced bioactivity of vascular endothelial growth factor (VEGF) may play a central role in this pathophysiology. Previous clinical studies have strongly suggested that relaxin is a systemic and renal vasodilator. In nonclinical studies, relaxin administration to monkeys has been associated with increased vessel density in the endometrium, and in previous human trials relaxin administration has been highly correlated with increased menstrual bleeding in women. VEGF has been proposed as a mechanism for these endometrial effects. Together, these data suggest that relaxin may be able to relieve systemic and renal vasoconstriction and improve placental perfusion in women with preeclampsia. As a first step in the development program for relaxin in this indication, a multicenter, randomized, double-blind, placebo-controlled phase I safety study in women with severe preeclampsia has been launched in the USA. Three doses of relaxin, 3, 10, and 30 microg/kg of body weight/day, or placebo, will be administered for up to 72 h in women admitted to the hospital for management of their disease. Although the trial is primarily focused on safety, signs of efficacy, such as changes in blood pressure and renal markers, will also be assessed.
    MeSH term(s) Clinical Trials, Phase I as Topic ; Female ; Humans ; Pre-Eclampsia/drug therapy ; Pregnancy ; Relaxin/therapeutic use ; Research Design
    Chemical Substances Relaxin (9002-69-1)
    Language English
    Publishing date 2009-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 211003-9
    ISSN 1749-6632 ; 0077-8923
    ISSN (online) 1749-6632
    ISSN 0077-8923
    DOI 10.1111/j.1749-6632.2009.03838.x
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  6. Article ; Online: Relaxin: review of biology and potential role in treating heart failure.

    Teichman, Sam L / Unemori, Elaine / Teerlink, John R / Cotter, Gad / Metra, Marco

    Current heart failure reports

    2010  Volume 7, Issue 2, Page(s) 75–82

    Abstract: Relaxin is a naturally occurring human peptide initially identified as a reproductive hormone. More recently, relaxin has been shown to play a key role in the maternal hemodynamic and renal adjustments that accommodate pregnancy. An understanding of ... ...

    Abstract Relaxin is a naturally occurring human peptide initially identified as a reproductive hormone. More recently, relaxin has been shown to play a key role in the maternal hemodynamic and renal adjustments that accommodate pregnancy. An understanding of these physiologic effects has led to the evaluation of relaxin as a pharmacologic agent for the treatment of patients with acute heart failure. Preliminary results have been encouraging. In addition, the other known biologic properties of relaxin, including anti-inflammatory effects, extracellular matrix remodeling effects, and angiogenic and anti-ischemic effects, all may play a role in potential benefits of relaxin therapy. Ongoing, large-scale clinical testing will provide additional insights into the potential role of relaxin in the treatment of heart failure.
    MeSH term(s) Female ; Heart Failure/drug therapy ; Hemodynamics/drug effects ; Humans ; Pregnancy ; Relaxin/pharmacology ; Relaxin/therapeutic use ; Vasodilation/drug effects
    Chemical Substances Relaxin (9002-69-1)
    Language English
    Publishing date 2010-04-27
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2151202-4
    ISSN 1546-9549 ; 1546-9530
    ISSN (online) 1546-9549
    ISSN 1546-9530
    DOI 10.1007/s11897-010-0010-z
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  7. Article ; Online: A randomized, double-blind, placebo-controlled trial of relaxin for cervical ripening in post-delivery date pregnancies.

    Weiss, Gerson / Teichman, Sam / Stewart, Dennis / Nader, David / Wood, Susan / Unemori, Elaine

    Annals of the New York Academy of Sciences

    2009  Volume 1160, Page(s) 385–386

    Abstract: Recombinant human relaxin was used to attempt cervical ripening in post-delivery date pregnancies. High doses of relaxin were safe but did not advance cervical ripening or induce labor. ...

    Abstract Recombinant human relaxin was used to attempt cervical ripening in post-delivery date pregnancies. High doses of relaxin were safe but did not advance cervical ripening or induce labor.
    MeSH term(s) Cervical Ripening/drug effects ; Double-Blind Method ; Female ; Humans ; Injections, Intraventricular ; Pregnancy ; Relaxin/administration & dosage ; Relaxin/adverse effects ; Relaxin/blood ; Relaxin/pharmacology
    Chemical Substances Relaxin (9002-69-1)
    Language English
    Publishing date 2009-04
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 211003-9
    ISSN 1749-6632 ; 0077-8923
    ISSN (online) 1749-6632
    ISSN 0077-8923
    DOI 10.1111/j.1749-6632.2008.03794.x
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  8. Article ; Online: Liver function, in-hospital, and post-discharge clinical outcome in patients with acute heart failure-results from the relaxin for the treatment of patients with acute heart failure study.

    van Deursen, Vincent M / Edwards, Christopher / Cotter, Gad / Davison, Beth A / Damman, Kevin / Teerlink, John R / Metra, Marco / Felker, G Michael / Ponikowski, Piotr / Unemori, Elaine / Severin, Thomas / Voors, Adriaan A

    Journal of cardiac failure

    2014  Volume 20, Issue 6, Page(s) 407–413

    Abstract: Background: Elevated plasma concentrations of liver function tests are prevalent in patients with chronic heart failure (HF). Little is known about liver function in patients with acute HF. We aimed to assess the prevalence and prognostic value of ... ...

    Abstract Background: Elevated plasma concentrations of liver function tests are prevalent in patients with chronic heart failure (HF). Little is known about liver function in patients with acute HF. We aimed to assess the prevalence and prognostic value of serial measurements of liver function tests in patients admitted with acute decompensated HF.
    Methods: We investigated liver function tests from all 234 patients from the Relaxin for the Treatment of Patients With Acute Heart Failure study at baseline and during hospitalization. The end points were worsening HF through day 5, 60-day mortality or rehospitalization, and 180-day mortality.
    Results: Mean age was 70 ± 10 years, 56% were male, and most patients were in New York Heart Association functional class III/IV (73%). Abnormal liver function tests were frequently found for alanine transaminase (ALT; 12%), aspartate transaminase (AST; 21%), alkaline phosphatase (12%), and total bilirubin (19%), and serum albumin (25%) and total protein (9%) were decreased. In-hospital changes were very small. On a continuous scale, baseline ALT and AST were associated with 180-day mortality (hazard ratios [HRs; per doubling] 1.52 [P = .030] and 1.97 [P = .013], respectively) and worsening HF through day 5 (HRs [per doubling] 1.72 [P = .005] and 1.95 [P = .008], respectively). Albumin was associated with 180-day mortality (HR 0.86; P = .001) but not with worsening HF (HR 0.95; P = .248). Total protein was associated with only worsening HF (HR 0.91; P = .004).
    Conclusions: Abnormal liver function tests are often present in patients with acute HF and are associated with an increased risk for mortality, rehospitalization, and in-hospital worsening HF.
    MeSH term(s) Acute Disease ; Aged ; Aged, 80 and over ; Female ; Follow-Up Studies ; Heart Failure/blood ; Heart Failure/drug therapy ; Heart Failure/mortality ; Hospitalization/trends ; Humans ; Liver/physiology ; Liver Function Tests/mortality ; Liver Function Tests/trends ; Male ; Middle Aged ; Patient Discharge/trends ; Relaxin/therapeutic use ; Survival Rate/trends ; Treatment Outcome
    Chemical Substances Relaxin (9002-69-1)
    Language English
    Publishing date 2014-06
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1281194-4
    ISSN 1532-8414 ; 1071-9164
    ISSN (online) 1532-8414
    ISSN 1071-9164
    DOI 10.1016/j.cardfail.2014.03.003
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  9. Article ; Online: Effects of serelaxin in subgroups of patients with acute heart failure: results from RELAX-AHF.

    Metra, Marco / Ponikowski, Piotr / Cotter, Gad / Davison, Beth A / Felker, G Michael / Filippatos, Gerasimos / Greenberg, Barry H / Hua, Tsushung A / Severin, Thomas / Unemori, Elaine / Voors, Adriaan A / Teerlink, John R

    European heart journal

    2013  Volume 34, Issue 40, Page(s) 3128–3136

    Abstract: Aim: Patients hospitalized for acute heart failure (AHF) differ with respect of many clinical characteristics which may influence their prognosis and response to treatment. We have assessed possible differences in the effects of serelaxin on dyspnoea ... ...

    Abstract Aim: Patients hospitalized for acute heart failure (AHF) differ with respect of many clinical characteristics which may influence their prognosis and response to treatment. We have assessed possible differences in the effects of serelaxin on dyspnoea relief, 60 Day outcomes and 180 Day mortality across patient subgroups in the RELAX-AHF trial.
    Methods and results: Subgroups were based on pre-specified covariates (age, sex, race, geographic region, estimated glomerular filtration rate, time from presentation to randomization, baseline systolic blood pressure, history of diabetes, atrial fibrillation, ischaemic heart disease, cardiac devices, i.v. nitrates at randomization). Other covariates which may modify the efficacy of AHF treatment were also analysed. Subgroup analyses did not show any difference in the effects of serelaxin vs. placebo on dyspnoea relief or on the incidence of cardiovascular death or rehospitalizations for heart failure or renal failure at 60 days. Nominally significant interactions between some patient subgroups and the effects of serelaxin on 180 days cardiovascular and all-cause mortality were noted but should be interpreted cautiously due to the number of comparisons and the low incidence of deaths in the subgroups at lower risk.
    Conclusion: The effects of serelaxin vs. placebo appeared to be similar across subgroups of patients in RELAX-AHF.
    MeSH term(s) Acute Disease ; Adult ; Aged ; Cardiotonic Agents/administration & dosage ; Cause of Death ; Double-Blind Method ; Dyspnea/mortality ; Dyspnea/prevention & control ; Female ; Heart Failure/drug therapy ; Heart Failure/mortality ; Hospitalization/statistics & numerical data ; Humans ; Infusions, Intravenous ; Male ; Middle Aged ; Natriuretic Peptide, Brain/blood ; Peptide Fragments/blood ; Recombinant Proteins/administration & dosage ; Relaxin/administration & dosage ; Treatment Outcome
    Chemical Substances Cardiotonic Agents ; Peptide Fragments ; Recombinant Proteins ; pro-brain natriuretic peptide (1-76) ; serelaxin protein, human ; Natriuretic Peptide, Brain (114471-18-0) ; Relaxin (9002-69-1)
    Language English
    Publishing date 2013-09-02
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 603098-1
    ISSN 1522-9645 ; 0195-668X
    ISSN (online) 1522-9645
    ISSN 0195-668X
    DOI 10.1093/eurheartj/eht371
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  10. Article ; Online: First clinical experience with intravenous recombinant human relaxin in compensated heart failure.

    Dschietzig, Thomas / Teichman, Sam / Unemori, Elaine / Wood, Susy / Boehmer, Julia / Richter, Christoph / Baumann, Gert / Stangl, Karl

    Annals of the New York Academy of Sciences

    2009  Volume 1160, Page(s) 387–392

    Abstract: Relaxin is upregulated and plays a compensatory role in human heart failure. We therefore determined the safety of and dose response to human relaxin in stable patients with heart failure. Sixteen patients were treated with open-label intravenous relaxin ...

    Abstract Relaxin is upregulated and plays a compensatory role in human heart failure. We therefore determined the safety of and dose response to human relaxin in stable patients with heart failure. Sixteen patients were treated with open-label intravenous relaxin in three sequential dose cohorts and monitored hemodynamically during the 24-h infusion and postinfusion periods. The safety demonstrated in group A (treatment for 8 h each with dosages equivalent to 10, 30, and 100 microg/kg/day) allowed escalation to group B (240, 480, and 960 microg/kg/day), and the highest safe dose, 960 microg/kg/day, was selected for a 24-h dosing in group C. Relaxin showed no relevant adverse effects and produced hemodynamic effects consistent with systemic vasodilation, i.e., trends toward increases in the cardiac index and decreases in pulmonary wedge pressure, without inducing hypotension. The first therapeutic use of relaxin in human heart failure demonstrated favorable hemodynamic effects and indicated that it may be of value in the treatment of this widespread disease.
    MeSH term(s) Drug Administration Schedule ; Heart Failure/drug therapy ; Humans ; Infusions, Intravenous ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/adverse effects ; Recombinant Proteins/therapeutic use ; Relaxin/administration & dosage ; Relaxin/adverse effects ; Relaxin/therapeutic use ; Treatment Outcome
    Chemical Substances Recombinant Proteins ; Relaxin (9002-69-1)
    Language English
    Publishing date 2009-04
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 211003-9
    ISSN 1749-6632 ; 0077-8923
    ISSN (online) 1749-6632
    ISSN 0077-8923
    DOI 10.1111/j.1749-6632.2008.03819.x
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