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Trial record 84 of 242 for:    furosemide

Aquaresis Utility for Hyponatremic Acute Heart Failure Study (AQUA-AHF)

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ClinicalTrials.gov Identifier: NCT02183792
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Tien Ng, University of Southern California

Brief Summary:

Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with worse prognosis. In addition to its prognostic value, hyponatremia may have importance during the acute management of HF. We've recently shown that acute or chronic hyponatremia, especially <130 mEq/L, was associated with higher loop diuretic dose requirements and more frequent need for escalation of the diuretic regimen to achieve the same level of diuresis as normonatremic HF patients. Aquaresis with tolvaptan represents a potentially advantageous approach to the management of volume overload in HF, especially in patients presenting with concomitant hyponatremia. The purpose of the current study is to prospectively evaluate the comparative efficacy and safety of a tolvaptan-based diuretic regimen compared to conventional diuresis with a furosemide-based regimen on short-term clinical and treatment outcomes in hyponatremic acute HF patients.

This will be a prospective, open-label, parallel-group, randomized study comparing a tolvaptan-based aquaretic regimen to a conventional continuous infusion loop diuretic-based regimen of furosemide. Up to 55 (target sample size of 50) adult subjects admitted with acute HF and signs of volume overload, and serum sodium less than 135 mEq/L will be randomized to tolvaptan or furosemide treatment arms. The initial 24 hours of study treatment will compare tolvaptan monotherapy to furosemide monotherapy. After the initial 24 hours, treatment regimens may be altered to achieve desired clinical goals. Patients will be followed for up to 96 hours and at discharge for study purposes.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: Tolvaptan Drug: Furosemide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aquaresis Utility for Hyponatremic Acute Heart Failure Study
Study Start Date : December 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Tolvaptan
Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)
Drug: Tolvaptan
Other Name: Samsca

Active Comparator: Furosemide
Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)
Drug: Furosemide
Other Name: Lasix




Primary Outcome Measures :
  1. Median Urine Output at 24 Hours Post Randomization [ Time Frame: 24 hours post randomization ]

Secondary Outcome Measures :
  1. Median Change in Serum Creatinine at 24 Hours Post Randomization [ Time Frame: 24 hours post randomization ]
    Comparison between baseline and 24 hours post randomization concentrations.


Other Outcome Measures:
  1. Total Urine Output [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  2. Glomerular Filtration Rate (Estimated) [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  3. In-hospital Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  4. Mean Hourly Urine Output at 24 Hours [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  5. Serum Sodium Change [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.

  6. Weight Change [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.

  7. Cumulative Furosemide Dose [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  8. Cumulative Metolazone Use [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  9. Change in Self-rated Dyspnea [ Time Frame: At baseline, 24 and 96 hours post randomization ]
  10. Acute Worsening of Kidney Function (Defined as an Increase in Serum Creatinine 0.3 mg/dL or 25% Above Baseline) [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  11. Incidence of Electrolyte Abnormalities [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Hypo- and hyperkalemia defined as outside the range of 3.5 to 5.0 mEq/L Hypo- and hypermagnesemia defined as outside the range of 1.5-2.4 mEq/L

  12. Symptomatic Hypotension [ Time Frame: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  13. Change in Plasma Renin Activity [ Time Frame: At baseline, 24 and 96 hours post randomization ]
  14. Change in Copeptin [ Time Frame: At baseline, 24 and 96 hours post randomization ]
  15. Change in N-terminal Pro-B-type Natriuretic Peptide [ Time Frame: At baseline, 24 and 96 hours post randomization ]
  16. Change in Cystatin C [ Time Frame: At baseline, 24 and 96 hours post randomization ]
  17. Change in Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) [ Time Frame: At baseline, 24, 48, 72 and 96 hours post randomization ]
  18. Hospital Length of Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute HF with signs or symptoms of volume overload [i.e. elevated jugular venous pulsation (JVP), rales, edema]
  • Serum sodium < 135 mEq/L at time of or within first 48 hours of hospitalization
  • Randomized within 48 hours of presentation to hospital
  • ≥ 18 years of age
  • Informed consent

Exclusion Criteria:

  • Severe symptomatic hyponatremia requiring acute treatment
  • Severe renal impairment upon admission (creatinine clearance < 20 mL/min)
  • Renal replacement therapy dependent, or requiring upon admission
  • Acute coronary syndrome on admission
  • Requires or has a mechanical circulatory support device
  • Evidence of cardiogenic shock requiring intravenous vasopressors
  • Pregnancy
  • Patient requiring concomitant use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183792


Locations
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United States, California
Keck Medical Center of USC
Los Angeles, California, United States, 90033
LAC+USC Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Otsuka America Pharmaceutical
Investigators
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Principal Investigator: Tien Ng, PharmD University of Southern California
Principal Investigator: Uri Elkayam, MD University of Southern California
  Study Documents (Full-Text)

Documents provided by Tien Ng, University of Southern California:

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Responsible Party: Tien Ng, Associate Professor of Clinical Pharmacy and Medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT02183792     History of Changes
Other Study ID Numbers: HS-13-00705
First Posted: July 8, 2014    Key Record Dates
Results First Posted: May 27, 2019
Last Update Posted: May 27, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Furosemide
Heart Failure
Heart Diseases
Cardiovascular Diseases
Tolvaptan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antidiuretic Hormone Receptor Antagonists