Heart FailureFLUID-HFNCT05931614
Liberal or Restricted Fluid Intake in Patients With Heart Failure
A study testing Free fluid intake in people with Heart Failure, run by Region Stockholm at 1 site in Sweden.
Trial summary
Heart failure is the most common cause of admission to hospital and is associated with high morbidity and mortality. Treatment options consist of medical- and device treatment and self-care strategies, where fluid restriction has been one of the components in the self-care management of patients with chronic heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Free fluid intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteSweden
- Study dates
- 14 Feb 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with left ventricual heart failure (HFrEF, HFmEF)
- Physical, cognitive and linguistic ability to carry out all aspects of the study
Who cannot join
- Reversible cause of HF (thyroid disorders, severe anemia, etc.)
- Hyponatremia at baseline (sodium <130 mmol/L)
- eGFR at baseline <30mL/min/1.73m2
- Scheduled cardiac surgery, coronary intervention (percutaneous coronary intervention or coronary artery bypass graft surgery) within 3 months
- Myocardial infarction within 3 months
- Comorbidity for which fluid restriction or unlimited fluid intake is advised
- Life expectancy <6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Carolin Nymark, PhD, +46725955887, carolin.nymark@regionstockholm.se
About this study
Official title: Liberal or Restricted Fluid Intake in Patients With Heart Failure: a Non-inferiority Randomized Controlled Trial
Heart failure is the most common cause of admission to hospital and is associated with high morbidity and mortality. Treatment options consist of medical- and device treatment and self-care strategies, where fluid restriction has been one of the components in the self-care management of patients with chronic heart failure. The medical treatment has progressed and improved over the years and considerably over the last few years, which has decreased symptoms and improved physical function of these patients. Despite our great success in the medical treatment of heart failure, we still face challenges in hospital readmissions and treatment strategies. It contributes to the increased need of evidence on, if and how, fluid intake and fluid restriction should be used as a self-care method. Fluid restriction as a self-care treatment is still commonly recommended in heart failure management although the scientific clinical evidence is lacking. Fluid restriction is associated with a higher degree of thirst and lower rated quality of life, and there is no consensus on how fluid restriction should be used, no plan for individualized treatment and no agreement on how fluid restriction should be a part of the patient self-care treatment. There is therefore a need for knowledge on how heart failure patients are affected by fluid restriction regarding clincal signs and symptoms of heart failure, quality of life, physical function, readmission to hospital or heart failure events. The primary aim of the study is to investigate whether a free fluid intake is safe compared to a restricted fluid intake, regarding clinical signs of heart failure measured as the presence of B-lines and/or an increase in NT-proBNP. The secondary aim is to clarify whether an unlimited fluid intake can improve quality of life and reduce thirst without affecting heart failure symptoms, physical activity, hospital readmissions and/or heart failure events.
- Conditions
- Heart Failure
- Being tested
- Free fluid intake
- Keywords
- Quality of life, Intervention, Thirst distress, Symptoms, Physical capacity, Hospital readmissions, Lung ultrasound, Fluid intake, B-lines, NT-ProBNP, Heart failure, Fluid restriction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free fluid intakeBehavioural
Patients are recommended a free fluid intake
| Study group | Role | What they receive |
|---|---|---|
| Free fluid intake | Experimental | Patients have no restrictions of fluid intake Receives: Behavioral: Free fluid intake |
| Restricted fluid intake | No intervention | Patients are recommended a restricted fluid intake of 1500 mL/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
B-lines
The patients will be investigated with lung ultrasound to screen for B-lines (comet tail artifacts) to assess pulmonary congestion
Measured: 12 weeks
NT-proBNP
Specific biomarkers for heart failure (blood test)
Measured: 12 weeks
Secondary outcomes (9)
Heart failure symptoms
Symptoms of heart failure measured by questionnaires
Measured: 12 weeks
HRQoL
Health related quality of life measured with EQ5D
Measured: 12 weeks
Thirst distress
Measured: 12 weeks
Self-Care
Self-care in chronic illness, measured by a questionnaire
Measured: 12 weeks
IVC
Ultrasound of Inferior Vena Cava (IVC) diameter and respiratory variation.
Measured: 12 weeks
Pleural effusion
Lungultrasound with screening for pleural effusion
Measured: 12 weeks
Physical Capacity
Physical Capacity measured by six minutes walktest
Measured: 12 weeks
Hospital readmissions
Hospital readmissions within three months
Measured: 12 weeks
Heart failure events
Contact with helathcare due to heart failure symtoms, increased use of diuretics with/without admission etc.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start14 Feb 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- St Goran's Hospital, Ersta Hospital, Sweden
- Responsible party
- Principal investigator, Carolin Nymark, Region Stockholm
- Investigators
- Carolin Nymark, PhD, Principal investigator, Karolinska Universitetssjukhuset, Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931614
- Sponsor's protocol ID
- K 2023-3124
- Acronym
- FLUID-HF
- Status last verified
- Feb 2026
- First submitted
- 16 Jun 2023
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal or Restricted Fluid Intake in Patients With Heart Failure: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05931614
- Acronym / sponsor ID
- FLUID-HF / K 2023-3124
- Conditions
- Heart Failure
- Keywords
- Quality of life, Intervention, Thirst distress, Symptoms, Physical capacity, Hospital readmissions, Lung ultrasound, Fluid intake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- St Goran's Hospital, Ersta Hospital, Sweden
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Jul 2023 (actual)
- 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.
Heart failure is the most common cause of admission to hospital and is associated with high morbidity and mortality. Treatment options consist of medical- and device treatment and self-care strategies, where fluid restriction has been one of the components in the self-care management of patients with chronic heart failure. The medical treatment has progressed and improved over the years and considerably over the last few years, which has decreased symptoms and improved physical function of these patients. Despite our great success in the medical treatment of heart failure, we still face challenges in hospital readmissions and treatment strategies. It contributes to the increased need of evidence on, if and how, fluid intake and fluid restriction should be used as a self-care method. Fluid restriction as a self-care treatment is still commonly recommended in heart failure management although the scientific clinical evidence is lacking. Fluid restriction is associated with a higher degree of thirst and lower rated quality of life, and there is no consensus on how fluid restriction should be used, no plan for individualized treatment and no agreement on how fluid restriction should be a part of the patient self-care treatment. There is therefore a need for knowledge on how heart failure patients are affected by fluid restriction regarding clincal signs and symptoms of heart failure, quality of life, physical function, readmission to hospital or heart failure events. The primary aim of the study is to investigate whether a free fluid intake is safe compared to a restricted fluid intake, regarding clinical signs of heart failure measured as the presence of B-lines and/or an increase in NT-proBNP. The secondary aim is to clarify whether an unlimited fluid intake can improve quality of life and reduce thirst without affecting heart failure symptoms, physical activity, hospital readmissions and/or heart failure events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free fluid intake | Experimental | Behavioral: Free fluid intakePatients have no restrictions of fluid intake |
| Restricted fluid intake | No intervention | –Patients are recommended a restricted fluid intake of 1500 mL/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with left ventricual heart failure (HFrEF, HFmEF)
- Physical, cognitive and linguistic ability to carry out all aspects of the study
Key exclusion criteria (7 listed)
- Reversible cause of HF (thyroid disorders, severe anemia, etc.)
- Hyponatremia at baseline (sodium <130 mmol/L)
- eGFR at baseline <30mL/min/1.73m2
- Scheduled cardiac surgery, coronary intervention (percutaneous coronary intervention or coronary artery bypass graft surgery) within 3 months
- Myocardial infarction within 3 months
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 |
|---|---|---|
| Free fluid intakePatients are recommended a free fluid intake | Behavioural | Free fluid intake |
Primary outcome
B-lines
Time frame: 12 weeks
The patients will be investigated with lung ultrasound to screen for B-lines (comet tail artifacts) to assess pulmonary congestion
NT-proBNP
Time frame: 12 weeks
Specific biomarkers for heart failure (blood test)
9 secondary outcomes
Heart failure symptoms
Time frame: 12 weeks
HRQoL
Time frame: 12 weeks
Thirst distress
Time frame: 12 weeks
Self-Care
Time frame: 12 weeks
IVC
Time frame: 12 weeks
Pleural effusion
Time frame: 12 weeks
Physical Capacity
Time frame: 12 weeks
Hospital readmissions
Time frame: 12 weeks
Heart failure events
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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A Study of Bimagrumab in Participants With HFpEF
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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.
Carolin Nymark, PhD principal investigator
Karolinska Universitetssjukhuset, Heart and Vascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free fluid intake in people with Heart Failure, run by Region Stockholm at 1 site in Sweden.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolin Nymark, PhD (+46725955887, carolin.nymark@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-lines (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 24 Feb 2026.