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Troponin I Release After High Diuretic Doses (Tra-HSS-Fur)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419132
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : November 1, 2011
Information provided by (Responsible Party):
Gaspare Parrinello, University of Palermo

Brief Summary:
High values of cardiac troponin (Ct) in acute heart failure (ADHF) identify patients (pts) at higher risk and worsened prognosis. A Ct increase during therapy indicates the need for more appropriate intervention, aimed at compensating cardiac disease and effectively minimizing myocardial wall stress and subsequent cytolysis. This study evaluated the effects of an intravenous high-dose of furosemide with or without small-volume hypertonic saline solution (HSS)on myocardial cytolysis in ADHF pts.

Condition or disease Intervention/treatment Phase
ADHF Drug: Furosemide Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of High Furosemide Doses Alone or With Hypertonic Saline on Troponin I Myocardial Release in Acute Decompensated Heart Failure: a Double Blind Study.
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Placebo Comparator: High doses furosemide
administration of furosemide alone
Drug: Furosemide
125-250 mf furosemide bid
Other Name: diuretics

Experimental: HSS plus furosemide
administration of hypertonic saline solution plus high doses of furosemide bid
Drug: Furosemide
125-250 mg furosemide bid
Other Name: diuretics

Primary Outcome Measures :
  1. troponin I plasma levels (pg/ml) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks ]
    troponin I will be evaluated at entry and at dicharge

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • signs/symptoms of heart failure;
  • New York Heart Association (NYHA) functional Class III or IV on admission due to an exacerbation of symptoms with at least 1 class deterioration;
  • evidence of systolic dysfunction on echocardiographic examination on admission (EF<45%);
  • BNP levels on admission > 100pg/mL

Exclusion Criteria:

  • NYHA class < III on admission or without a NYHA class improvement on discharge;
  • acute coronary syndrome,
  • pulmonary thromboembolism,
  • cardiac tamponade,
  • pericarditis,
  • renal insufficiency (serum creatinine <2,5 mg/dL, BUN <60 mg/dL) or those on dialysis;
  • chronic liver disease,
  • pleuro-pneumonia,
  • blood and autoimmune diseases,
  • concomitant other important co-morbidity,
  • cerebral vascular disease,
  • dementia,
  • cancer,
  • uncompensated diabetes,
  • took non-steroid anti-inflammatory drugs (NSAID)
  • declining to provide informed consent,
  • patients requiring pacemaker implantation and those with issues of excessive alcohol consumption

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 identifier (NCT number): NCT01419132

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Department of Internal and Specialty Medicine
Palermo, Italy, 90127
Gaspare PArrinello
Palermo, Italy, 90127
GF Ingrasasia Hospital
Palermo, Italy, 90132
Sponsors and Collaborators
University of Palermo
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Study Chair: Parrinello Gaspare, MD University of Palermo

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gaspare Parrinello, Effects of High Furosemide Doses Alone or With Hypertonic Saline on Troponin I Myocardial Release in Acute Decompensated Heart Failure: a Double Blind Study., University of Palermo Identifier: NCT01419132     History of Changes
Other Study ID Numbers: Tra-HSS-Fur
12/11 UNIPA-AOUP ( Other Identifier: University of Palermo, Policlinico General Hospital )
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2011
Keywords provided by Gaspare Parrinello, University of Palermo:
hypertonic saline solution
troponin I
Additional relevant MeSH terms:
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Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action