Phase 3 N=110 A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
Edema, Cardiac
Primary: Body Weight (Amount of Change) — -0.45; -1.54 Kg — p=<0.0001
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Phase 2 N=157 A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Cardiac Edema (CHF)
Primary: Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8 — -1.96; -1.74; -1.4; -1.84 kg
Phase 3 N=20 A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
Cardiac Edema
Primary: Body Weight — -1.68; -2.14 Kg
Phase 3 N=52 A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)
Cardiac Edema
Primary: Body Weight — -2.05; -1.31; -2.9 Kg
Phase 2 N=122 A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)
Heart Failure, Congestive · Edema
Primary: Body Weight — -0.53; -1.62; -1.35; -1.85 Kg — p=0.0074
N/A N=14 Effects of Exercise Training on Fluid Instability in Heart Failure Patients
Heart Failure
Primary: Bioelectrical Impedance Change — 47.52; 47.1; 41.27; 46.8 Percentage of Extra Cellular Fluid
N/A N=349 Impact of Heart Failure Center Program on Cardiac Outcomes in Patients With Heart Failure
Death · Congestive Heart Failure
Primary: All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations — 36; 15; 41; 18…
Phase 4 N=129 Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema
Acute Cardiogenic Pulmonary Edema
Primary: Number of Patients Who Were Intubated — 5; 4; 10 participants
N/A N=47 FAST (Fluid Accumulation Status Trial)
Congestive Heart Failure · Cardiomyopathy · Dyspnea
Primary: Number of Subjects With at Least 30 Days of Daily Impedance Measurements — 47; 106 participants
Phase 2 N=130 B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial
Heart Failure · Heart Failure Acute · Acute Cardiac Pulmonary Edema
Primary: Number of Participants With B-lines ≤ 15 at the Conclusion of ED AHF Management — 7; 10 Participants
Phase 3 N=188 Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)
Heart Failure
Primary: Change in Serum Creatinine — -0.04; 0.23 mg/dL
N/A N=66 Congestive Heart Failure Weight Study
Congestive Heart Failure
Primary: The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients — 2.47; 3.09 kilograms — p=<.001
Phase 3 N=308 Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)
Heart Failure
Primary: Patient Well Being, as Determined by a Visual Analog Scale — 4236; 4372.7; 4170.8; 4429.6 units on a scale
Phase 4 N=57 Loop Diuretics Administration and Acute Heart Failure
Acute Heart Failure
Primary: Evaluation of Mean Urine Output Volume During the Infusion Period — 2505; 2140 mL — p=0.04
Phase 4 N=519 Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)
Acute Decompensated Heart Failure · Volume Overload
Primary: Successful Decongestion — 79; 108 Participants
N/A N=50 B-type Natriuretic Peptide as a Surrogate Marker Guiding Post-operative Fluid Off-loading
Fluid Over-load
Primary: Length of Stay — 4; 6 days
N/A N=335 Heart Failure Study: The Atlanta Cardiomyopathy Consortium
Heart Failure
Primary: Death, Heart Transplant, Left Ventricular Assist Device Implantation — 35 participants
N/A N=50 FAST PV and mGFR™ Technology in Congestive Heart Failure
CHF
Primary: Number of Participants With Treatment Related AEs and Serious Adverse Events (SAEs) — 0 Participants
Phase 4 N=34 Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure
Heart Failure
Primary: Acetazolamide Arm: Natriuresis 24 h — 324; 300; 211; 190 mmol — p=0.515
N/A N=114 Non-invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema
Cardiogenic Pulmonary Oedema
Primary: Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit — 5; 5 Participants — p=1.000
N/A N=11 Exercise Training in Heart Failure: Changes in Cardiac Structure and Function
Heart Failure
Primary: Change in Left Ventricular Systolic Function. — .82; -1.90 percent LVEF — p=.14
Phase 2 N=58 Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction
Congestive Heart Failure
Primary: Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment — 87.19…
N/A N=186 Thoracic Ultrasonography for Pulmonary Edema in Patients With Pre-Eclampsia
Pre-eclampsia
Primary: Detection of Fluid in the Lungs — 2; 3 Participants — p=.162
Phase 2 N=74 Intensive Glycemic Control for Congestive Heart Failure Exacerbation
Congestive Heart Failure · Diabetes Mellitus
Primary: Hospital Length of Stay — 7; 8 days
N/A N=100 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
Acute Decompensated Heart Failure
Primary: Total Urine Sodium Output — 1082; 423 mmol of sodium — p=<0.001
Phase 4 N=36 Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
Heart Failure · CHF
Primary: Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30…
Phase 3 N=257 Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure
Heart Failure · Dyspnea
Primary: Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours — 20; 26 Participants — p=0.315
N/A N=746 Danger Signs in Heart Failure- Effects of Video Education
Heart Failure; With Decompensation
Primary: Number of Participants With HF-related Healthcare Resource Utilization (HCRU) — 64; 59 Participants
Phase 3 N=45 Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
Congestive Heart Failure
Primary: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs — 77.8 percentage of participants
Phase 1 N=36 A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure
Heart Failure, Congestive
Primary: Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline — 0.4946; 0.3346; 0.5078; 0.3253 Liter — p=0.0029