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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark Identifier:
First received: December 10, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

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 Intervention
Heart Failure
Other: Fluid restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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


  • 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
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 identifier: NCT01748331

Contact: Finn Gustafsson, MD, PhD, DMSci 004535459743
Contact: Louise Balling, MD 004523451679

Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Olav Wendelboe Nielsen, MD, DMSc    004535316448   
Principal Investigator: Olav W Nielsen, MD, DMSci         
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark, 1718
Contact: Finn Gustafsson, MD, PhD, DMSci    004535459743   
Contact: Louise Balling, MD    004523451679   
Principal Investigator: Finn Gustafsson, MD, PhD, DMSci         
Sub-Investigator: Louise Balling, MD         
Sponsors and Collaborators
Finn Gustafsson
Rigshospitalet, Denmark
Principal Investigator: Finn Gustafsson, MD, PhD, DMSci Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Finn Gustafsson, Staff Cardiologist, PhD, DMSci, Rigshospitalet, Denmark Identifier: NCT01748331     History of Changes
Other Study ID Numbers: H-1-2012-060
Study First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Heart Failure
Fluid restriction

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Metabolic Diseases
Water-Electrolyte Imbalance processed this record on October 13, 2015