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Pulmonary Hypertension in Sickle Cell Anemia

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141. Effects of HQK-1001 in Patients With Sickle Cell Disease

Study Description Go to Brief Summary: The purpose of this study is to evaluate the effects of HQK-1001 on Hb F in subjects with sickle cell disease. Condition or disease Intervention/treatment Phase Sickle Cell Disease Sickle Cell Anemia Sickle Cell Disorders Hemoglobin S Disease Sickling Disorder Due to Hemoglobin S Drug: HQK-1001 Drug: Placebo Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 77 participants Allocation (...) Cell Sickle Cell Trait Pathologic Processes Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn

2012 Clinical Trials

142. Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease

Nephropathy Drug: Atorvastatin Drug: Placebo Phase 2 Detailed Description: It is well recognized that sickle cell disease (SCD) is characterized by a vasculopathy, with involvement of multiple organs including the brain, lung, spleen, and kidney. This results in multiple clinical complications, including ischemic stroke, pulmonary hypertension, autosplenectomy, as well as albuminuria and chronic renal disease. Several recent studies have confirmed the association of both albuminuria and renal dysfunction (...) disease endothelial function albuminuria atorvastatin soluble fms-like tyrosine kinase-1 Additional relevant MeSH terms: Layout table for MeSH terms Kidney Diseases Anemia, Sickle Cell Albuminuria Urologic Diseases Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Proteinuria Urination Disorders Urological Manifestations Signs and Symptoms Atorvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular

2012 Clinical Trials

143. Carbon Monoxide Levels and Sickle Cell Disease Severity

, and race with the sickle cell disease group. Design: Participants will be screened with a medical history. Participants with sickle cell disease will provide a blood sample and have a heart function test. They will also breathe into a bag to provide an exhaled breath sample. Healthy volunteers will provide an exhaled breath sample. No treatment or care will be provided as part of this study. Condition or disease Sickle Cell Disease Sickle Cell Anemia Anemia, Sickle Cell Detailed Description: Sickle (...) Institute (NHLBI) ClinicalTrials.gov Identifier: Other Study ID Numbers: 120069 12-H-0069 First Posted: March 8, 2012 Last Update Posted: April 5, 2019 Last Verified: November 4, 2015 Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ): Hemolytic Severity Erythrocyte Sickle Cell Disease SD Additional relevant MeSH terms: Layout table for MeSH terms Anemia Anemia, Sickle Cell Hematologic Diseases Anemia, Hemolytic, Congenital

2012 Clinical Trials

144. A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease

A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save (...) this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details

2012 Clinical Trials

145. Vascular Function Intervention Trial in Sickle Cell Disease

with clinically significant non-SCD related disease including: Stage III or above HIV - or receiving ART therapy regardless of AIDS stage Tuberculosis infection Blood transfusion within previous 30 days Previously diagnosed clinical pulmonary hypertension or cardiac dysfunction or clinical signs of pulmonary hypertension (loud pulmonary second heart sound) or heart failure (displaced apex beat, high jugular venous pressure, enlarged liver, peripheral oedema) Low visual acuity at baseline (<6/9 using (...) Sponsor: London School of Hygiene and Tropical Medicine Collaborator: Wellcome Trust Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine Study Details Study Description Go to Brief Summary: Sickle cell disease (SCD) is the most common inherited disorder worldwide affecting 300,000 births annually, most occuring in sub-Saharan Africa (SSA) where poor detection and care result in high childhood mortality, malnutrition, illness and disability in survivors. SCD

2012 Clinical Trials

146. Sickle-cell disease and the heart: review of the current literature. (Abstract)

Sickle-cell disease and the heart: review of the current literature. Sickle cell disease (SCD) is an inherited chronic haemolytic anaemia whose clinical manifestations arise from the tendency of the haemoglobin to polymerize and deform red blood cells into the characteristic sickle shape due to a single nucleotide change in the β-globin. Vascular occlusion of small and large vessels can lead to chronic damage of multiple organs including brain, lung, bone, kidney, liver, spleen, and retina (...) . However, the extent to which SCD impacts myocardial function is not very clear. Cardiovascular manifestations include both right and left ventricular systolic and diastolic dysfunction, elevated cardiac output, cardiomegaly and myocardial ischaemia. Progressive heart damage from iron overload occurs in patients requiring routine transfusion therapy. Pulmonary hypertension resulting from intravascular haemolysis has also been recognized as a major complication that independently correlates

2012 British journal of haematology

147. Cardiovascular abnormalities in sickle cell disease. Full Text available with Trip Pro

Cardiovascular abnormalities in sickle cell disease. Sickle cell disease is characterized by recurrent episodes of ischemia-reperfusion injury to multiple vital organ systems and a chronic hemolytic anemia, both contributing to progressive organ dysfunction. The introduction of treatments that induce protective fetal hemoglobin and reduce infectious complications has greatly prolonged survival. However, with increased longevity, cardiovascular complications are increasingly evident (...) , with the notable development of a progressive proliferative systemic vasculopathy, pulmonary hypertension (PH), and left ventricular diastolic dysfunction. Pulmonary hypertension is reported in autopsy studies, and numerous clinical studies have shown that increased pulmonary pressures are an important risk marker for mortality in these patients. In epidemiological studies, the development of PH is associated with intravascular hemolysis, cutaneous leg ulceration, renal insufficiency, iron overload, and liver

2012 Journal of the American College of Cardiology

148. Renal Cell Carcinoma

of Bellini Rare, often presenting at an advanced stage (N+ 44% and M1 33% at diagnosis). The hazard ratio in CSS in comparison with ccRCC is 4.49 [32]. High, very aggressive. Median survival 30 months [58]. Surgery/Response to targeted therapies was poor [59]. Renal medullary carcinoma Very rare. Mainly young black men with sickle cell trait High, very aggressive, median survival is 5 months [58]. Surgery/different chemotherapy regimes, radiosensitive. Translocation RCC (TRCC) Xp11.2 Rare, mainly younger (...) indicators for this patient group have been selected: 1. Thorax CT for staging of pulmonary metastasis. 2. Proportion of patients with T1aN0M0 tumours undergoing nephron sparing surgery as first treatment. 3. The proportion of patients treated within 6 weeks after diagnosis. 4. The proportion of patients with metastatic RCC offered treatment with targeting agents. 5. Proportion of patients who undergo minimally invasive or operative treatment as first treatment who die within 30 days. 2.3 Peer review

2015 European Association of Urology

149. Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

-driven, up to 4.1 years) ] Change from baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52 and at end of treatment [ Time Frame: Baseline and up to 4.1 years) ] Number of blood pressure (BP) exacerbation events per 100 patient years [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 4.1 years) ] Percentage of participants with least one BP exacerbation event during study [ Time Frame: Randomization (Day 1 (...) -unrelated kidney transplant within 52 weeks after study start (Day 1). Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at screening. Transferrin saturation (TSAT) (screening only): <=20%. Aplasias: History of bone marrow aplasia or pure red cell aplasia. Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer

2016 Clinical Trials

150. Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)

; Week 28 to end of trial) [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ] Change from Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52 and at end of treatment [ Time Frame: Baseline and up to 3.3 years ] Number of blood pressure (BP) exacerbation events per 100 patient years [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ] Number of participants (...) (TSAT) (screening only): <=20%. Aplasias: History of bone marrow aplasia or pure red cell aplasia. Other causes of anemia: Untreated Pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding <=4 weeks prior to screening through to randomization (Day 1). MI or acute coronary syndrome: <=4 weeks prior to screening through

2016 Clinical Trials

151. Treatment of Sickle Cell Anemia With Stem Cell Transplant

efficacious and sufficiently gentle to apply to patients with sickle cell anemia and related disorders. It is proposed to characterize the efficacy and toxicity of this regimen in high risk patients with sickle cell anemia using criteria for patient selection that have been accepted in prior BMT trials in patients with sickle cell disease, specifically only the subset of patients whose prior clinical behavior indicates that they are at high risk for serious morbidity and early mortality. In addition (...) treatment with hydroxyurea is not considered the standard of care in these entities (2) the presence of high hemoglobin F levels in patients with sickle cell anemia and documented Hereditary Persistence of Fetal Hemoglobin (HPFH) in which hydroxyurea is not considered the standard of care (3) severe adverse reactions to hydroxyurea in patients with sickle cell anemia based on, but not limited to, count suppression, GI intolerance, and dermatomyositis Patient unwillingness to be compliant

2011 Clinical Trials

152. FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis

cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition. Any prior functioning organ transplant or a scheduled organ transplantation, or anephric. Anticipated elective surgery that could lead to significant blood loss during the study period. Anticipated use of dapsone or acetaminophen (paracetamol) >2.0 g/day, or >500 mg per dose repeated every 6 hours for more than 3 days. Serum (...) . Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (eg, deep venous thrombosis or pulmonary embolism) within 52 weeks prior to Day 1. Uncontrolled hypertension in the opinion of the investigator (eg, that requires change in anti-hypertensive medication within 2 weeks prior to randomization). Diagnosis or suspicion (eg, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma as shown on screening renal ultrasound. History of malignancy except

2015 Clinical Trials

153. FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease

erythropoiesis (eg, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease). Clinically significant gastrointestinal bleeding. Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition. Any prior functioning organ transplant or a scheduled organ (...) from baseline in blood pressure confirmed by repeat measurement at next visit unless anti-hypertensive medications are changed. Mean change from baseline in predialysis and postdialysis mean arterial blood pressure [ Time Frame: Weeks 23-27 ] Mean arterial blood pressure measured pre-and post-dialysis. Number of subjects with treatment-emergent adverse events (TEAEs). [ Time Frame: Week 1 to up to Week 53 ] Number of subjects with treatment-emergent adverse events (TEAEs). Percent of subjects

2015 Clinical Trials

154. Pulmonary Hypertension

), and transforming growth factor-beta (TGF-β). Focal coagulation at the endothelial surface should not be confused with chronic thromboembolic pulmonary hypertension, in which pulmonary hypertension is caused by organized pulmonary emboli. Increased pulmonary venous pressure is typically caused by disorders that affect the left side of the heart and raise left chamber pressures, which ultimately lead to elevated pressure in the pulmonary veins. Elevated pulmonary venous pressures can cause acute damage (...) secondary causes; some cases are idiopathic. In pulmonary hypertension, pulmonary vessels become constricted and/or obstructed. Severe pulmonary hypertension leads to right ventricular overload and failure. Symptoms are fatigue, exertional dyspnea, and, occasionally, chest discomfort and syncope. Diagnosis is made by finding elevated pulmonary artery pressure (estimated by echocardiography and confirmed by right heart catheterization). Treatment is with pulmonary vasodilators and diuretics. In some

2013 Merck Manual (19th Edition)

155. Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia

that the mortality was related to pulmonary hypertension. It is the aim of this study to retrospectively evaluate patients who have had multiple echocardiograms and to determine if patients who had either a normalization of their TR jet velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart catheterization had a similar mortality rate to those with persistently elevated TR jet velocity. Condition or disease Intervention/treatment Sickle Cell Anemia Pulmonary Hypertension Other (...) : Namita Sood Information provided by (Responsible Party): Namita Sood, Ohio State University Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. Previous studies have shown that an elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of mortality. This initial data only examined an isolated TR jet velocity. It was presumed

2011 Clinical Trials

156. Markers of Severe Vaso-Occlusive Painful Episode Frequency in Children and Adolescents with Sickle Cell Anemia. Full Text available with Trip Pro

Markers of Severe Vaso-Occlusive Painful Episode Frequency in Children and Adolescents with Sickle Cell Anemia. To identify factors associated with frequent severe vaso-occlusive pain crises in a contemporary pediatric cohort of patients with sickle cell anemia (SCA) enrolled in a prospective study of pulmonary hypertension and the hypoxic response in sickle cell disease.Clinical and laboratory characteristics of children with SCA who had ≥3 severe pain crises requiring health care (...) in the preceding year were compared with those of subjects with <3 such episodes.Seventy-five children (20%) reported ≥3 severe pain episodes in the preceding year, and 232 (61%) had none. Frequent pain episodes were associated with older age (OR, 1.2; 95% CI, 1.1-1.3; P < .0001), α-thalassemia trait (OR 3.5; 1.6-6.7; P = .002), higher median hemoglobin (OR 1.7; 95% CI: 1.2-2.4; P < .003), and lower lactate dehydrogenase concentration (OR 1.82; 95% CI: 1.07-3.11; P = .027). Children with high pain frequency

2011 Journal of Pediatrics

157. Changes in Bi-ventricular Function After Hematopoietic Stem Cell Transplant as Assessed by Speckle Tracking Echocardiography. (Abstract)

Changes in Bi-ventricular Function After Hematopoietic Stem Cell Transplant as Assessed by Speckle Tracking Echocardiography. Hematopoietic stem cell transplant (HSCT) is a therapeutic option for patients with sickle cell disease (SCD) and severe acquired aplastic anemia (SAA). HSCT may have beneficial effects on ventricular function in damaged myocardium. We hypothesized improvement in ventricular performance and pulmonary hypertension following HSCT with strain echocardiography in SCD and SAA (...) initial decline (from - 11.1 to - 17.5, P = 0.009) but was comparable to baseline (P = 0.43). Other measurements of bi-ventricular function did not change significantly. Tricuspid regurgitation velocities as surrogates for pulmonary hypertension improved in the subset of patients with baseline elevated values although data points were limited. Abnormal myocardial systolic function was detected at baseline with strain imaging. HSCT was associated with initial worsening longitudinal strain values

2017 Pediatric Cardiology

158. Childhood Hematopoietic Cell Transplantation (PDQ®): Health Professional Version

Risk of graft rejection Low Low–moderate Moderate–high Moderate–high Moderate–high Time to immune reconstitution a Rapid (6–12 mo) Moderate (6–18 mo) Slow (6–24 mo) Slow (6–24 mo) Slow (9–24 mo) b Risk of acute GVHD Moderate Moderate Moderate Low Low Risk of chronic GVHD High Moderate Low Low Low BM = bone marrow; EBV-LPD = Epstein-Barr virus–associated lymphoproliferative disorder; GVHD = graft-versus-host disease; HCT = hematopoietic cell transplantation; PBSCs = peripheral blood stem cells (...) A, von Stackelberg A, Schrappe M, et al.: Allogeneic hematopoietic SCT in children with ALL: current concepts of ongoing prospective SCT trials. Bone Marrow Transplant 41 (Suppl 2): S71-4, 2008. [ ] Bertaina A, Merli P, Rutella S, et al.: HLA-haploidentical stem cell transplantation after removal of αβ+ T and B cells in children with nonmalignant disorders. Blood 124 (5): 822-6, 2014. [ ] Handgretinger R, Chen X, Pfeiffer M, et al.: Feasibility and outcome of reduced-intensity conditioning

2016 PDQ - NCI's Comprehensive Cancer Database

159. Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia

hematological disease including those affecting platelets, white or red blood cells (e.g., antibody-mediated pure red cell aplasia, sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other cause of anemia other than renal disease diagnosed prior to Week -4. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's (...) ). Myocardial infarction or acute coronary syndrome: Within the 8 weeks prior to Week -4. Stroke or transient ischemic attacks (TIAs): Within the 8 weeks prior to Week -4. Heart failure: Class III/IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system diagnosed prior to Week -4. Hypertension: Defined using pre-dialysis vitals (Week -4) of diastolic blood pressure >100 millimeters of mercury (mmHg) or systolic blood pressure >170 mmHg. Thrombotic disease

2014 Clinical Trials

160. Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

values, as measured by central laboratory, during the Screening Period. Subject's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN. Exclusion Criteria: Main Exclusion: Subject has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization. Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes (...) : August 7, 2018 Sponsor: Astellas Pharma Europe B.V. Collaborator: FibroGen Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Europe B.V. ) Study Details Study Description Go to Brief Summary: This study is conducted to explore a new therapy for anemia in patients with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood

2014 Clinical Trials

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