Clinical trials: Volume Overload
Respiratory Insufficiency
Description of Fluid Balance in Patients With Acute Respiratory Failure
The specific aim of this study is to gather data on fluid balance, intravenous medication administration, electrolyte balance, and diuretic and dialysis use in patients with acute respiratory failure who might benefit from a…
- Trial name
- NCT02523872
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Smiths Medical, ASD, Inc.
Heart Failure, Congestive Heart Failure
PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiomyopathy
- Trial name
- NCT00253357
- Where
- 28 sites in United States, Austria and 11 more
- Volunteers
- 450 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiovascular Diseases, Cardiovascular Diseases Risk
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm…
- Conditions
- Cardiovascular Diseases, Cardiovascular Diseases Risk, Cardiac Conduction System Disease, Bundle/Fascicular Abnormalities
- Trial name
- Cor360 (NCT07775976)
- Testing
- COR Wearable ECG Monitoring, Cor360 Clinician-Facing Decision-Aid Reporting
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
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)
Acute Decompensated Heart Failure, Fluid Overload
A Feasibility Study on Ultrafiltration and Blood Volume Measurements
The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100).
- Trial name
- NCT04241718
- Testing
- Aquadex FlexFlow System and BVA-100
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Nuwellis, Inc.
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.
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
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, 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
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
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, 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
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.
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)
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.
Heart Failure
Furosemide Pharmacodynamics and Pharmacokinetics After Subcutaneous or Oral Administration
The purpose of this pilot study is to investigate the pharmacodynamic and pharmacokinetic parameters of a novel furosemide formulation administered subcutaneously as compared to oral furosemide.
- Trial name
- FUROPHARM-HF (NCT02350725)
- Testing
- Furosemide injection solution for subcutaneous administration (80 mg), Oral Furosemide tablets (80 mg)
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- scPharmaceuticals, Inc.
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.
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
- Trial name
- NCT03255226
- Testing
- Tolvaptan
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Heart Failure
Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients
One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as…
- Trial name
- NCT01439009
- Testing
- Tolvaptan
- Where
- 8 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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