Hypertonic Saline Solution in Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Edimar Alcides Bocchi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00555685
First received: November 8, 2007
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.


Condition Intervention Phase
Heart Failure
Renal Failure
Hyponatremia
Drug: NaCl 7,5% (Hypertonic Saline Solution)
Drug: NaCl 0,9%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Hypertonic Saline Solution in Decompensated Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Occurrence of renal disfunction [ Time Frame: During hospital admission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of hyponatremia [ Time Frame: During hospital admission ] [ Designated as safety issue: No ]
  • Improvement of congestive phenomena [ Time Frame: During hospital admission ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Group of patients that will receive hypertonic saline solution (NaCl 7,5%)
Drug: NaCl 7,5% (Hypertonic Saline Solution)
Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days
Placebo Comparator: B
Group of patients that will receive placebo
Drug: NaCl 0,9%
Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 years old
  • Heart failure according to Framingham criteria
  • Episode of acute decompensation,with need of in-hospital treatment
  • Presence of congestive phenomena

Exclusion Criteria:

  • Patient denial
  • Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography
  • Rheumatic disease
  • Restrictive cardiomyopathy
  • Alcohol abuse
  • Chronic obstructive pulmonary disease
  • Cancer
  • Pulmonary embolism during the last 6 months
  • Surgical procedures or acute illness during the last 30 days
  • Chronic or acute infection
  • Any other circumstance that may hamper patient prognosis for the next 6 months
  • Serum creatine over 3.0mg/dL
  • Serum potassium over 5.5 mEqs/L
  • Any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555685

Locations
Brazil
Heart Institute of São Paulo University Medical School
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Edimar A Bocchi, Professor Heart Failure (InCor) University of São Paulo Medical School
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edimar Alcides Bocchi, Heart Failure Team Director, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00555685     History of Changes
Other Study ID Numbers: FAPESP 2007/04048-7
Study First Received: November 8, 2007
Last Updated: June 6, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Heart Failure
Renal failure
Hyponatremia

Additional relevant MeSH terms:
Heart Failure
Hyponatremia
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014