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

Heart Failure Clinical Trial

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Official title:

The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01748331
• Other study ID #: H-1-2012-060
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2012
• Last updated: October 26, 2015
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: Finn Gustafsson, MD, PhD, DMSci
• Phone: 004535459743
• Email: finn.gustafsson[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hyponatremia

Intervention

Other:
• Fluid restriction
Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Department of Cardiology, Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Finn Gustafsson	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change in plasma vasopressin and copeptin		5 days	No
Secondary	Change in blood pressure, heart rate, weight and oedemas		5 days	No
Secondary	Change in dyspnoea assessed by the patient		5 days	No
Secondary	Number of days until clinical stability		5 days	No
Secondary	The correlation between hospitalization time and plasma sodium		5 days	Yes
Secondary	Correlation between fluid restriction and change in kidney function		5 days	Yes
Secondary	Patient assessment of fluid restriction		5 days	No
Secondary	Patient compliance to fluid restriction		5 days	No