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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gaspare Parrinello, University of Palermo
ClinicalTrials.gov Identifier:
NCT01419132
First received: August 15, 2011
Last updated: October 29, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
ADHF
 Drug: Furosemide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
Drug Information available for: Furosemide
U.S. FDA Resources

Further study details as provided by University of Palermo:

Primary Outcome Measures:
  • troponin I plasma levels (pg/ml) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks ] [ Designated as safety issue: No ]
    troponin I will be evaluated at entry and at dicharge


Estimated Enrollment: 60
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419132

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

Publications:

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
ClinicalTrials.gov Identifier: NCT01419132     History of Changes
Other Study ID Numbers: Tra-HSS-Fur, 12/11 UNIPA-AOUP
Study First Received: August 15, 2011
Last Updated: October 29, 2011
Health Authority: Italy: National Bioethics Committee

Keywords provided by University of Palermo:
furosemide
hypertonic saline solution
troponin I

Additional relevant MeSH terms:
Diuretics
Furosemide
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013