Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management
NCT ID: NCT01584557
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2012-06-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tolvaptan, Samsca
Tolvaptan, Samsca, uncoated tablet, 30 mg, once per day, up to 7 days.
Tolvaptan or Samsca
uncoated tablet, 30mg, once per day, for up to 7 days.
sugar pill
placebo, sugar pill
placebo or sugar pill
sugar pill
Interventions
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Tolvaptan or Samsca
uncoated tablet, 30mg, once per day, for up to 7 days.
placebo or sugar pill
sugar pill
Eligibility Criteria
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Inclusion Criteria
2. Males and females 18 years of age or older.
3. NYHA Class III or IV on admission to the hospital.
4. Able to understand content of and willing to provide written informed consent
5. Dyspnea, measured by the 5-point current dyspnea scale (moderately short of breath or worse), within 2 hours of randomization and dosing.
The following must be met within 12 hours of randomization.
6. The subject must have signs of extracellular volume expansion, defined as two or more of the following five: Signs of RHF ( jugular venous distention, pitting edema (≥1+), ascites) and/or Signs of LHF (pulmonary congestion on chest x-ray, pulmonary rales)
7. Have at least one of the following:
* eGFR \< 60ml/min/1.73m2, OR
* serum sodium ≤ 134 mEq/L, OR
* urine output ≤ 125 ml/hr over anytime frame of at least 2 hours, following administration of IV furosemide of at least 40mg. See table below.
Time Period (hr) Cumulative UO (mL) 2 \<250 3 \<375 4 \<500 5 \<625 6 \<750 7 \<875 8 \<1000
Exclusion Criteria
2. Inability to provide written informed consent.
3. Cardiac surgery within 60 days prior to study randomization.
4. Acute Coronary Syndrome (ACS) or percutaneous coronary intervention within 30 days prior to study randomization.
5. Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
6. Planned electrophysiologic (EP) device implantation within 7 days following study randomization.
7. Subjects who are on cardiac mechanical support.
8. Co-morbid condition with an expected survival less than six months.
9. History of a cerebrovascular accident within the last 30 days.
10. Hemodynamically significant uncorrected primary cardiac valvular disease.
11. Hypertrophic cardiomyopathy (obstructive or non-obstructive).
12. Uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
13. History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
14. Chronic uncontrolled diabetes mellitus as determined by the investigator.
15. Supine systolic arterial blood pressure \< 90 mmHg.
16. Serum creatinine \> 3.5 mg/dL or undergoing dialysis.
17. Hemoglobin \< 9 g/dL
18. History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazepril).
19. Inability to take oral medications.
20. Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted.
21. Previous exposure to tolvaptan within 7 days prior to randomization.
22. Subjects with refractory, end-stage, heart failure defined as subjects who are appropriate candidates for specialized treatment strategies, such as ventricular assist devices, continuous positive IV inotropic therapy, or hospice care.
23. Ultrafiltration within 7 days prior to randomization or planned.
24. Active gout
25. Serum sodium \>144 mEq/L
18 Years
ALL
No
Sponsors
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Cardiovascular Clinical Sciences Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Marvin Konstam, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Clinical Sciences Inc
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
The Heart Center Research
Huntsville, Alabama, United States
Greater Los Angeles VA Medical Center
Los Angeles, California, United States
University of Florida Health Science Ctr. Jacksonville
Jacksonville, Florida, United States
MIMA Century Research Associates
Melbourne, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University Cardiology Associates, LLC
Augusta, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
Advocate Medical Group - Oakbrook
Naperville, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
St. Vincent Medical Group
Indianapolis, Indiana, United States
CardioSpecialists Group
Munster, Indiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Advanced Cardiovascular Specialists
Shreveport, Louisiana, United States
Louisiana Heart Center and Research
Slidell, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Crittenton Hospital Medical Center
Rochester, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Bryan Heart Institute
Lincoln, Nebraska, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Caromont Heart/Gaston Memorial Hospital
Gastonia, North Carolina, United States
Duke Cardiology of Lumberton Research/Southeastern Regional Medical Cente
Lumberton, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
University of Cincinnati
Cincinnatti, Ohio, United States
Dayton Heart Center
Dayton, Ohio, United States
The Sisters of Mercy of Hamilton, Ohio dba Mercy Hospital Fairfield
Fairfield, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Memorial Hospital of RI
Pawtucket, Rhode Island, United States
The Miriam Hosptial
Providence, Rhode Island, United States
University of Texas Health Science Center
Houston, Texas, United States
The Heart Hospital Baylor Plano - Research Insititute
Plano, Texas, United States
CV Group Central Lynchburg/Stroobants Heart Center
Lynchburg, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Konstam MA, Kiernan M, Chandler A, Dhingra R, Mody FV, Eisen H, Haught WH, Wagoner L, Gupta D, Patten R, Gordon P, Korr K, Fileccia R, Pressler SJ, Gregory D, Wedge P, Dowling D, Romeling M, Konstam JM, Massaro JM, Udelson JE; SECRET of CHF Investigators, Coordinators, and Committee Members. Short-Term Effects of Tolvaptan in Patients With Acute Heart Failure and Volume Overload. J Am Coll Cardiol. 2017 Mar 21;69(11):1409-1419. doi: 10.1016/j.jacc.2016.12.035.
Other Identifiers
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CCSF-2011-001
Identifier Type: -
Identifier Source: org_study_id
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