Clinical trials: Fluid Overload
Heart Failure
Monitor Patients With Acute Heart Failure
This is a prospective, multi-center, non-randomized study to evaluate performance of an external monitor for heart failure patients
- Trial name
- ACUTE (NCT00919828)
- Testing
- Avivo System
- Volunteers
- 60 people
- Sponsor
- Corventis, Inc.
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.
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, 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
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
Transfusional Hemosiderosis
Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food
This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20 centers. All patients who met the study criteria and were taking, beginning or resuming treatment with Deferasirox were allowed.
- Trial name
- NCT00845871
- Testing
- deferasirox:
- Where
- 23 sites in United States
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
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
Acute Decompensated Heart Failure
DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to Diuretics
The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.
- Trial name
- NCT05876078
- Testing
- Doraya catheter
- Where
- 10 sites in Germany, Italy and 3 more
- Volunteers
- 25 people
- Sponsor
- Revamp Medical Ltd.
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.
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.
Congestive Heart Failure
Reprieve ADHF EFS IDE
This is a prospective, single arm, early feasibility study (EFS) designed to evaluate the safety and device performance of The RenalGuard System in the management of patients admitted with signs and symptoms of congestive heart…
- Trial name
- NCT03866551
- Testing
- Reprieve Cardiovascular System
- Volunteers
- 40 people
- Sponsor
- CardioRenal Systems, Inc.
Acute Decompensated Heart Failure
DORAYA-HF Early Feasibility Study
The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.
- Trial name
- NCT05206422
- Testing
- Doraya Catheter
- Where
- 14 sites in United States
- Volunteers
- 21 people
- Sponsor
- Revamp Medical Inc.
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
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)
Hyponatremia With Normal Extracellular Fluid Volume
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.
- Trial name
- NCT00660959
- Testing
- lixivaptan
- Where
- 71 sites in United States, Belgium and 4 more
- Volunteers
- 106 people
- Sponsor
- CardioKine Inc.
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
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)
Clinical Need for Craniotomy or Craniectomy, Clinical Need for Cranioplasty
A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.
A multi-center, early feasibility study of using the Mechanical Tissue Resuscitation™ (MTR®) therapy system for removal of excess fluid in subjects who have had a portion of their skull removed to expose the dura/brain and…
- Trial name
- NCT06201429
- Testing
- Mechanical Tissue Resuscitation™ (MTR®)
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Renovo Concepts, Inc.
Chronic Heart Failure, Fluid Overload
Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry
The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients.
- Conditions
- Chronic Heart Failure, Fluid Overload, Acute Decompensated Heart Failure, Edema
- Trial name
- REFORM-HF II (NCT06401109)
- Testing
- AquaPass
- Volunteers
- 30 people
- Sponsor
- AquaPass Medical Ltd.
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.