Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia (Decongest)

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.
 
ClinicalTrials.gov Identifier: NCT01748331
Recruitment Status : Unknown
Verified October 2015 by Finn Gustafsson, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : December 12, 2012
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine the effect of fluid restriction and the neurohormonal mechanisms in the development of hyponatremia in patients with congestive heart failure and hyponatremia. The hypothesis is that strict fluid restriction leads to a larger increase in plasma sodium than standard treatment in patients with decompensated heart failure associated with hyponatremia. A secondary hypothesis is that the neurohormonal change is greater in patients treated with strict fluid restriction versus standard treatment.

Condition or disease Intervention/treatment Phase
Heart Failure Hyponatremia Other: Fluid restriction Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure
Study Start Date : November 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Strict fluid restriction < 1 L/day
20 patients will be randomized to strict fluid restriction < 1 L/day
 Other: Fluid restriction
Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day
Moderate fluid restriction < 2.5 L/day
20 patients will be randomized to moderate fluid restriction < 2.5 L/day
 Other: Fluid restriction
Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in plasma sodium from day 1 to day 4: - Normalization of plasma sodium or - A significant change in plasma sodium of a minimum of 5 mmol/L from baseline to day 4 [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Change in plasma vasopressin and copeptin [ Time Frame: 5 days ]
  2. Change in blood pressure, heart rate, weight and oedemas [ Time Frame: 5 days ]
  3. Change in dyspnoea assessed by the patient [ Time Frame: 5 days ]
  4. Number of days until clinical stability [ Time Frame: 5 days ]
  5. The correlation between hospitalization time and plasma sodium [ Time Frame: 5 days ]
  6. Correlation between fluid restriction and change in kidney function [ Time Frame: 5 days ]
  7. Patient assessment of fluid restriction [ Time Frame: 5 days ]
  8. Patient compliance to fluid restriction [ Time Frame: 5 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Left Ventricular Ejection Fraction (LVEF) < 40

At least two of the following signs of decompensated heart failure and fluid retention:

  • Weight gain > 2 kg
  • Pulmonal Congestion
  • Jugular vein congestion
  • Peripheral oedemas
  • Hepatic congestion with ascites
  • Radiographic signs of fluid retention
  • Increased diuretic dose

And

  • New York Heart Association (NYHA) class III-IV
  • Plasma sodium < 135 mmol/L
  • Symptomatic heart failure and treatment with relevant heart failure medications (beta-blocker, diuretic, digoxin, angiotensin-converting-enzyme inhibitor, angiotensin-II receptor antagonist, spironolactone, hydralazine and/or nitrates)for at least 1 month
  • Hospitalization for decompensated heart failure within the last 48 hours
  • Given informed consent

Exclusion Criteria:

  • Plasma sodium ≥ 135 mmol/L before randomization
  • Reduced kidney function (creatinine > 200 μmol/L)
  • Severe hematologic disease
  • Hypovolemic hyponatremia (volume depletion or dehydration)
  • Intolerability to large or fast changes in fluid volume assessed by the investigator
  • Plasma sodium < 120 mmol/L accompanied by neurologic symptoms
  • Anuria
  • Symptomatic systolic blood pressure (supine systolic blood pressure < 90 mmHg)
  • Uncontrolled hypertension (systolic blood pressure > 180 mmHg)
  • Uncontrolled diabetes diabetes mellitus
  • Adrenal insufficiency
  • Acute myocardial infarction, sustained ventricular tachycardia or ventricular fibrillation within the last 30 days
  • Heart surgery within the last 60 days
  • Other severe heart disease: hypertrophic cardiomyopathy, severe heart valve disease, cardiac amyloidosis, active myocarditis, pericardial exudate which is hemodynamically significant
  • Left ventricular assist device (LVAD)
  • Planned revascularization procedure, electrophysiologic device implantation, mechanic left ventricular assist device, heart transplant or any other heart surgery procedures within the next 30 days
  • Cerebrovascular event within the last 6 months
  • Comorbidity with an expected survival < 6 months
  • Other reasons for hyponatremia: Primary syndrome of inappropriate antidiuretic hormone secretion (SIADH), primary polydipsia, head trauma, uncontrolled hypothyroidism, adrenal insufficiency or other known pharmacologically triggered hyponatremia which is reversible upon discontinuation of the drug, hyperglycemia (pseudohyponatremia), present abuse of alcohol
  • Pregnancy
  • Pregnant or fertile women who are not using safe contraception
  • Dementia
  • Unwilling or unable to give informed consent
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01748331


Contacts
Layout table for location contacts
Contact: Finn Gustafsson, MD, PhD, DMSci 004535459743 finn.gustafsson@regionh.dk
Contact: Louise Balling, MD 004523451679 louise.balling@dadlnet.dk

Locations
Layout table for location information
Denmark
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark, 1718
Contact: Finn Gustafsson, MD, PhD, DMSci    004535459743    finn.gustafsson@regionh.dk   
Contact: Louise Balling, MD    004523451679    louise.balling@dadlnet.dk   
Principal Investigator: Finn Gustafsson, MD, PhD, DMSci         
Sub-Investigator: Louise Balling, MD         
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Olav Wendelboe Nielsen, MD, DMSc    004535316448    owen0002@bbh.regionh.dk   
Principal Investigator: Olav W Nielsen, MD, DMSci         
Sponsors and Collaborators
Finn Gustafsson
Rigshospitalet, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Finn Gustafsson, MD, PhD, DMSci Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Finn Gustafsson, Staff Cardiologist, PhD, DMSci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01748331    
Other Study ID Numbers: H-1-2012-060
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Finn Gustafsson, Rigshospitalet, Denmark:
Heart Failure
Hyponatremia
Fluid restriction
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Hyponatremia
Heart Diseases
 Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases