Clinical trials: Volume Overload
Heart Failure, Congestive
PROTECT-1: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
The study is being conducted to examine whether KW-3902IV will result in greater improvement in signs and symptoms of heart failure, with less treatment failure than standard therapy, when it is added to IV loop diuretics in…
- Trial name
- NCT00328692
- Testing
- rolofylline
- Volunteers
- 932 people
- Sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Heart Failure, Congestive Heart Failure
Safety and Feasibility of the WhiteSwell System"
Early feasibility study to evaluate safety and performance of the WhiteSwell System in the treatment of fluid overload in hospitalized patients with acutely decompensated heart failure.
- Trial name
- SWIFTHF (NCT02863796)
- Testing
- WhiteSwell System
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- WhiteSwell, Limited
Heart Failure, Fluid Overload
Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers
This study aims to compare the pharmacokinetics and pharmacodynamics of subcutaneous (SC) and intravenous (IV) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffered to a neutral pH for SC…
- Trial name
- NCT06167707
- Testing
- SCP-111, Furosemide USP
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- scPharmaceuticals, Inc.
Hyponatremia, Euvolemia
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
- Conditions
- Hyponatremia, Euvolemia, Hypervolemia
- Trial name
- NCT00435591
- Testing
- Conivaptan
- Where
- 18 sites in United States, India and 1 more
- Volunteers
- 121 people
- Sponsor
- Cumberland Pharmaceuticals
Acute Heart Failure, Cardiac Decompensation
Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration
In patients with advanced volume overload, minimally invasive ultrafiltration treatment in the acute phase can have a positive effect on clinical outcome.
- Conditions
- Acute Heart Failure, Cardiac Decompensation, Volume Overload
- Trial name
- GENTLE-UF (NCT02769351)
- Testing
- periph. minimal invasive ultrafiltration
- Where
- 19 sites in Germany, Sweden and 1 more
- Volunteers
- 104 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Acute Kidney Injury, Fluid Overload
Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system.
- Trial name
- NCT04608149
- Testing
- Carpediem System
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Mozarc Medical US LLC
Congestive Heart Failure, Renal Impairment
Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.
- Trial name
- NCT00652782
- Testing
- rolofyline
- Volunteers
- 160 people
- Sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Healthy Participants
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986308 compared to placebo in healthy participants.
- Trial name
- NCT04763226
- Testing
- BMS-986308, Furosemide
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Heart Failure, Congestive Heart Failure
Alfapump Direct Sodium Removal (DSR) Feasibility Study
First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy.
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiorenal Syndrome, Volume Overload
- Trial name
- RED DESERT (NCT04116034)
- Testing
- alfapump DSR system
- Where
- 2 sites in Belgium, Georgia
- Volunteers
- 8 people
- Sponsor
- Sequana Medical N.V.
Hyponatremia
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.
- Trial name
- NCT01451411
- Testing
- Conivaptan hydrochloride
- Where
- 3 sites in United States, Colombia
- Volunteers
- 4 people
- Sponsor
- Cumberland Pharmaceuticals
Acute Renal Failure (ARF), Acute Kidney Injury (AKI)
Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry
A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set.
- Conditions
- Acute Renal Failure (ARF), Acute Kidney Injury (AKI), Fluid Overload in Dialysis Patients
- Trial name
- NCT06633029
- Testing
- Prismaflex HF20
- Where
- 5 sites in United States
- Volunteers
- 59 people
- Sponsor
- Vantive Health LLC
Heart Failure, ADHF
PK/PD Study of Subcutaneous Cenderitide Infusion in CHF Patients
The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus.
- Conditions
- Heart Failure, ADHF, Chronic Heart Failure, CHF
- Trial name
- NCT01316432
- Testing
- Cenderitide
- Where
- 5 sites in United States
- Volunteers
- 58 people
- Sponsor
- Nile Therapeutics
Hypervolemic Hyponatremia
International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia
To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.
- Trial name
- NCT00876876
- Testing
- Lixivaptan
- Volunteers
- 300 people
- Sponsor
- CardioKine Inc.
Congestive Heart Failure
Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure
The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure.
- Trial name
- NCT01055912
- Testing
- Lixivaptan
- Where
- 25 sites in United States
- Volunteers
- 170 people
- Sponsor
- CardioKine Inc.
Heart Failure, Volume Overload
Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0
This study is a multi-center, prospective, randomized (2:1), open-label study to evaluate the safety and efficacy of DSR therapy using the Infusate 2.0 peritoneal solution (composed of 30% icodextrin and 10% dextrose) in diuretic…
- Trial name
- MOJAVE (NCT05965934)
- Testing
- Direct Sodium Removal Infusate 2.0
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Sequana Medical N.V.
Euvolemic Hyponatremia, Hypervolemic Hyponatremia
Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
The registry is a multi-center, prospective, observational study designed to collect data in patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and hyponatremia secondary to syndrome of…
- Trial name
- HN Registry (NCT01240668)
- Where
- 79 sites in United States, Germany and 1 more
- Volunteers
- 5,028 people
- Sponsor
- Otsuka America Pharmaceutical
Kidney Disease, Peritoneal Dialysis (PD)
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.
- Conditions
- Kidney Disease, Peritoneal Dialysis (PD), End Stage Kidney Disease (ESRD)
- Trial name
- SCALE-PD (NCT07059962)
- Testing
- Bodyport Cardiac Scale
- Where
- 7 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Bodyport Inc.
Heart Failure, Ventricular Tachycardia
Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic…
- Conditions
- Heart Failure, Ventricular Tachycardia, Cardiac Desynchronization
- Trial name
- ConnectOptiVol (NCT00730548)
- Testing
- Device triggered remote telephone contact because of Care Alert
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Heart Failure, CKD Stage 3
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
- Trial name
- REFORM-HF (NCT06360380)
- Testing
- AquaPass System
- Where
- 10 sites in United States, Israel
- Volunteers
- 40 people
- Sponsor
- AquaPass Medical Ltd.
Heart Failure, Congestive
PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
The study is being conducted to examine whether KW-3902IV will result in greater improvement in signs and symptoms of heart failure, with less treatment failure than standard therapy, when it is added to IV loop diuretics in…
- Trial name
- NCT00354458
- Testing
- rolofylline
- Volunteers
- 1,102 people
- Sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)