Clinical trials: Hypervolemia
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 With Volume Overload
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload.
- Trial name
- NCT06506994
- Testing
- HRS-9057, Tolvaptan
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Fluid Overload
Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)
The ULTRA-Peds registry will employ a multi-center, single-arm, open-label, observational design to capture baseline, procedural and follow-up data on pediatric patients that have been treated (i.e., retrospective data from…
- Trial name
- ULTRA-Peds (NCT04644731)
- Testing
- Aquadex™ System
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- Nuwellis, Inc.
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
Heart Failure
Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.
To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.
- Trial name
- NCT05712746
- Testing
- Samtasu for I.V. infusion
- Where
- Japan
- Volunteers
- 1,600 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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.
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.
Hyponatremia
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
- Trial name
- NCT00578695
- Testing
- lixivaptan
- Where
- 287 sites in United States, Argentina and 13 more
- Volunteers
- 652 people
- Sponsor
- CardioKine 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.
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.
Congestive Heart Failure
Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)
The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the…
- Trial name
- NCT00124137
- Testing
- Aquadex system, IV diuretic
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Nuwellis, Inc.
Heart Failure (for Example, Fluid Overload), Heart Failure
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF)…
- Conditions
- Heart Failure (for Example, Fluid Overload), Heart Failure, Fluid Overload
- Trial name
- REVERSE-HF (NCT05318105)
- Testing
- Aquadex Smartflow® System, IV Loop Diuretics
- Where
- 15 sites in United States
- Volunteers
- 167 people
- Sponsor
- Nuwellis, 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.
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, 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
Intradialytic Hypotension, Hypervolemia
Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration
The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to further the investigators understanding of…
- Trial name
- NCT02264522
- Testing
- Place dialysis chair into position 3., Decrease dialysate temperature., Decrease ultrafiltration rate by 25%.
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Intelomed, Inc.
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, Volume Overload
Safety & Feasibility of DSR TherApy in Heart FAiluRe pAtients With Persistent Congestion
Feasibility and safety study of the alfapump DSR system in the treatment of volume overloaded heart failure subjects receiving high doses of loop diuretics.
- Trial name
- SAHARA (NCT04882358)
- Testing
- ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM, SGLT2 inhibitor
- Where
- 2 sites in Georgia
- Volunteers
- 24 people
- Sponsor
- Sequana Medical N.V.
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)
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