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

Primary Purpose

Heart Failure, Hyponatremia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fluid restriction
Sponsored by
Finn Gustafsson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Hyponatremia, Fluid restriction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Copenhagen University Hospital, RigshospitaletRecruiting
  • Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Strict fluid restriction < 1 L/day

Moderate fluid restriction < 2.5 L/day

Arm Description

20 patients will be randomized to strict fluid restriction < 1 L/day

20 patients will be randomized to moderate fluid restriction < 2.5 L/day

Outcomes

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

Secondary Outcome Measures

Change in plasma vasopressin and copeptin
Change in blood pressure, heart rate, weight and oedemas
Change in dyspnoea assessed by the patient
Number of days until clinical stability
The correlation between hospitalization time and plasma sodium
Correlation between fluid restriction and change in kidney function
Patient assessment of fluid restriction
Patient compliance to fluid restriction

Full Information

First Posted
December 10, 2012
Last Updated
October 26, 2015
Sponsor
Finn Gustafsson
Collaborators
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01748331
Brief Title
The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
Acronym
Decongest
Official Title
The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Finn Gustafsson
Collaborators
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Hyponatremia
Keywords
Heart Failure, Hyponatremia, Fluid restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strict fluid restriction < 1 L/day
Arm Type
Other
Arm Description
20 patients will be randomized to strict fluid restriction < 1 L/day
Arm Title
Moderate fluid restriction < 2.5 L/day
Arm Type
Other
Arm Description
20 patients will be randomized to moderate fluid restriction < 2.5 L/day
Intervention Type
Other
Intervention Name(s)
Fluid restriction
Intervention Description
Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in plasma vasopressin and copeptin
Time Frame
5 days
Title
Change in blood pressure, heart rate, weight and oedemas
Time Frame
5 days
Title
Change in dyspnoea assessed by the patient
Time Frame
5 days
Title
Number of days until clinical stability
Time Frame
5 days
Title
The correlation between hospitalization time and plasma sodium
Time Frame
5 days
Title
Correlation between fluid restriction and change in kidney function
Time Frame
5 days
Title
Patient assessment of fluid restriction
Time Frame
5 days
Title
Patient compliance to fluid restriction
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Finn Gustafsson, MD, PhD, DMSci
Phone
004535459743
Email
finn.gustafsson@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Louise Balling, MD
Phone
004523451679
Email
louise.balling@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finn Gustafsson, MD, PhD, DMSci
Organizational Affiliation
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
1718
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Finn Gustafsson, MD, PhD, DMSci
Phone
004535459743
Email
finn.gustafsson@regionh.dk
First Name & Middle Initial & Last Name & Degree
Louise Balling, MD
Phone
004523451679
Email
louise.balling@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Finn Gustafsson, MD, PhD, DMSci
First Name & Middle Initial & Last Name & Degree
Louise Balling, MD
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olav Wendelboe Nielsen, MD, DMSc
Phone
004535316448
Email
owen0002@bbh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Olav W Nielsen, MD, DMSci

12. IPD Sharing Statement

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

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