The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
Decongest
The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Nov 2012
Longer than P75 for not_applicable heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 10, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedOctober 28, 2015
October 1, 2015
4 years
December 10, 2012
October 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
5 days
Secondary Outcomes (8)
Change in plasma vasopressin and copeptin
5 days
Change in blood pressure, heart rate, weight and oedemas
5 days
Change in dyspnoea assessed by the patient
5 days
Number of days until clinical stability
5 days
The correlation between hospitalization time and plasma sodium
5 days
- +3 more secondary outcomes
Study Arms (2)
Strict fluid restriction < 1 L/day
OTHER20 patients will be randomized to strict fluid restriction \< 1 L/day
Moderate fluid restriction < 2.5 L/day
OTHER20 patients will be randomized to moderate fluid restriction \< 2.5 L/day
Interventions
Patients will be randomized to strict fluid restriction \< 1 L/day versus moderate fluid restriction \< 2.5 L/day
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finn Gustafssonlead
- Rigshospitalet, Denmarkcollaborator
Study Sites (2)
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 1718, Denmark
Bispebjerg Hospital
Copenhagen, 2400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Finn Gustafsson, MD, PhD, DMSci
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Staff Cardiologist, PhD, DMSci
Study Record Dates
First Submitted
December 10, 2012
First Posted
December 12, 2012
Study Start
November 1, 2012
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
October 28, 2015
Record last verified: 2015-10