Text Size

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

This study is currently recruiting participants.
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
  Purpose

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
Hyponatremia
 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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748331

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

Locations
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
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
ClinicalTrials.gov 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
Hyponatremia
Fluid restriction

Additional relevant MeSH terms:
Heart Failure
Hyponatremia
Heart Diseases
 Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013