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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01748331
Other study ID # H-1-2012-060
Secondary ID
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


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
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