NCT01419132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

1 month

First QC Date

August 15, 2011

Last Update Submit

October 29, 2011

Conditions

ADHF

Keywords

furosemidehypertonic saline solutiontroponin I

Outcome Measures

Primary Outcomes (1)

  • troponin I plasma levels (pg/ml)

    troponin I will be evaluated at entry and at dicharge

    participants will be followed for the duration of hospital stay, an expected average of 1 weeks

Study Arms (2)

High doses furosemide

PLACEBO COMPARATOR

administration of furosemide alone

Drug: Furosemide

HSS plus furosemide

EXPERIMENTAL

administration of hypertonic saline solution plus high doses of furosemide bid

Drug: Furosemide

Interventions

FurosemideDRUG

125-250 mg furosemide bid

Also known as: diuretics
HSS plus furosemide

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Internal and Specialty Medicine

Palermo, Palermo, 90127, Italy

Location

Gaspare PArrinello

Palermo, Palermo, 90127, Italy

Location

GF Ingrasasia Hospital

Palermo, Palermo, 90132, Italy

Location

Related Publications (3)

  • Kociol RD, Pang PS, Gheorghiade M, Fonarow GC, O'Connor CM, Felker GM. Troponin elevation in heart failure prevalence, mechanisms, and clinical implications. J Am Coll Cardiol. 2010 Sep 28;56(14):1071-8. doi: 10.1016/j.jacc.2010.06.016.

    PMID: 20863950RESULT

  • Parrinello G, Paterna S, Di Pasquale P, Torres D, Mezzero M, Cardillo M, Fasullo S, La Rocca G, Licata G. Changes in estimating echocardiography pulmonary capillary wedge pressure after hypersaline plus furosemide versus furosemide alone in decompensated heart failure. J Card Fail. 2011 Apr;17(4):331-9. doi: 10.1016/j.cardfail.2010.11.003. Epub 2010 Dec 24.

    PMID: 21440872RESULT

  • Parrinello G, Di Pasquale P, Torres D, Cardillo M, Schimmenti C, Lupo U, Iatrino R, Petrantoni R, Montaina C, Giambanco S, Paterna S. Troponin I release after intravenous treatment with high furosemide doses plus hypertonic saline solution in decompensated heart failure trial (Tra-HSS-Fur). Am Heart J. 2012 Sep;164(3):351-7. doi: 10.1016/j.ahj.2012.05.025. Epub 2012 Aug 17.

    PMID: 22980301DERIVED

MeSH Terms

Interventions

FurosemideDiuretics

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsNatriuretic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Parrinello Gaspare, MD

    University of Palermo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI 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 Record Dates

First Submitted

August 15, 2011

First Posted

August 17, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations

IT(3)