The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia (NCT01748331) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
Denmark40 participantsStarted 2012-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 with…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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