Heart FailureDecongestNCT01748331
The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
A study testing Fluid restriction in people with Heart Failure and Hyponatremia, run by Finn Gustafsson at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Hyponatremia
- What is being tested?
- Fluid restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2012to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 1718
Finn Gustafsson, MD, PhD, DMSci, 004535459743, finn.gustafsson@regionh.dk
Louise Balling, MD, 004523451679, louise.balling@dadlnet.dk
- Recruiting
Bispebjerg Hospital
Copenhagen, 2400
Olav Wendelboe Nielsen, MD, DMSc, 004535316448, owen0002@bbh.regionh.dk
Olav W Nielsen, MD, DMSci
About this study
Official title: The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure
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.
- Conditions
- Heart Failure, Hyponatremia
- Being tested
- Fluid restriction
- Keywords
- Heart Failure, Hyponatremia, Fluid restriction
- Medical subject headings
- Heart Failure, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid restrictionOther
Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day
| Study group | Role | What they receive |
|---|---|---|
| Strict fluid restriction < 1 L/day | Other | 20 patients will be randomized to strict fluid restriction < 1 L/day Receives: Other: Fluid restriction |
| Moderate fluid restriction < 2.5 L/day | Other | 20 patients will be randomized to moderate fluid restriction < 2.5 L/day Receives: Other: Fluid restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days
Secondary outcomes (8)
Change in plasma vasopressin and copeptin
Measured: 5 days
Change in blood pressure, heart rate, weight and oedemas
Measured: 5 days
Change in dyspnoea assessed by the patient
Measured: 5 days
Number of days until clinical stability
Measured: 5 days
The correlation between hospitalization time and plasma sodium
Measured: 5 days
Correlation between fluid restriction and change in kidney function
Measured: 5 days
Patient assessment of fluid restriction
Measured: 5 days
Patient compliance to fluid restriction
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finn Gustafsson
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, MD, PhD, DMSci, Principal investigator, Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748331
- Sponsor's protocol ID
- H-1-2012-060
- Acronym
- Decongest
- Status last verified
- Oct 2015
- First submitted
- 10 Dec 2012
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of the Vasopressin System of the Hemodynamics, Water Balance and Prognosis in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01748331
- Acronym / sponsor ID
- Decongest / H-1-2012-060
- Conditions
- Heart Failure, Hyponatremia
- Keywords
- Heart Failure, Hyponatremia, Fluid restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Finn GustafssonUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Nov 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strict fluid restriction < 1 L/day | Other | Other: Fluid restriction20 patients will be randomized to strict fluid restriction < 1 L/day |
| Moderate fluid restriction < 2.5 L/day | Other | Other: Fluid restriction20 patients will be randomized to moderate fluid restriction < 2.5 L/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age > 18 years
- Left Ventricular Ejection Fraction (LVEF) < 40
- Weight gain > 2 kg
- Pulmonal Congestion
- Jugular vein congestion
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid restrictionPatients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day | Other | Moderate fluid restriction < 2.5 L/day, Strict fluid restriction < 1 L/day |
Primary outcome
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
8 secondary outcomes
Change in plasma vasopressin and copeptin
Time frame: 5 days
Change in blood pressure, heart rate, weight and oedemas
Time frame: 5 days
Change in dyspnoea assessed by the patient
Time frame: 5 days
Number of days until clinical stability
Time frame: 5 days
The correlation between hospitalization time and plasma sodium
Time frame: 5 days
Correlation between fluid restriction and change in kidney function
Time frame: 5 days
Patient assessment of fluid restriction
Time frame: 5 days
Patient compliance to fluid restriction
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn Gustafsson, MD, PhD, DMSci principal investigator
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid restriction in people with Heart Failure and Hyponatremia, run by Finn Gustafsson at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Finn Gustafsson, MD, PhD, DMSci (004535459743, finn.gustafsson@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.