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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01748331
First received: December 10, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

December 10, 2012
December 10, 2012
November 2012
November 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Change in plasma vasopressin and copeptin [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Change in blood pressure, heart rate, weight and oedemas [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Change in dyspnoea assessed by the patient [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Number of days until clinical stability [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • The correlation between hospitalization time and plasma sodium [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Correlation between fluid restriction and change in kidney function [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Patient assessment of fluid restriction [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Patient compliance to fluid restriction [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Hyponatremia
Other: Fluid restriction
Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day
  • Strict fluid restriction < 1 L/day
    20 patients will be randomized to strict fluid restriction < 1 L/day
    Intervention: Other: Fluid restriction
  • Moderate fluid restriction < 2.5 L/day
    20 patients will be randomized to moderate fluid restriction < 2.5 L/day
    Intervention: Other: Fluid restriction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Finn Gustafsson, MD, PhD, DMSci 004535459743 finn.gustafsson@regionh.dk
Contact: Louise Balling, MD 004523451679 louise.balling@dadlnet.dk
Denmark
 
NCT01748331
H-1-2012-060
No
Finn Gustafsson, Rigshospitalet, Denmark
Finn Gustafsson
Rigshospitalet, Denmark
Principal Investigator: Finn Gustafsson, MD, PhD, DMSci Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
Rigshospitalet, Denmark
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP