Acute Heart Failure (AHF)RELIEF-AHFNCT07400991
Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure
A study testing Fluid restriction strategy and Thirst-driven, liberal fluid intake in people with Acute Heart Failure (AHF), run by Gødstrup Hospital at 1 site in Denmark.
Trial summary
The aim of this clinical trial is to learn whether a thirst-driven, liberal fluid-intake strategy is comparable to a fluid-restriction strategy in patients hospitalized for acute decompensated heart failure (ADHF). The study will also assess the safety of the intervention and its effects on thirst and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF)
- What is being tested?
- Fluid restriction strategy and Thirst-driven, liberal fluid intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2026to Aug 2029
- 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
- Age >18 years
- Hospitalized for ADHF as the primary diagnosis, meeting both of the following:
- ≥1 documented symptom of new or worsening heart failure (dyspnea, fatigue, decreased exercise tolerance, or symptom of end-organ hypoperfusion).
- Objective evidence of ADHF, defined as either:
- ≥2 physical signs (edema, ascites, pulmonary rales/crackles, increased JVP, S3 gallop, rapid weight gain due to fluid retention), OR ii. ≥1 physical sign AND ≥1 laboratory finding indicative of ADHF (BNP >500 ng/L or NT-proBNP >2000 ng/L if sinus rhythm, or BNP >750 ng/L or NT-proBNP >3000 ng/L if atrial fibrillation, radiological/ultrasound evidence of pulmonary congestion, echocardiographic sign [VCI >2.1 cm, LVOT VTI <15 cm, E/e' >14, D-dominant pulmonary venous inflow pattern], or invasive evidence [CVP >12 mmHg, PCWP >18 mmHg, CI <2.2 L/min/m2]).
- Treatment with ≥40 mg IV furosemide (or equivalent)
- Enrolment within 24 hours of admission
- Ability to provide informed consent
Who cannot join
- Requirement at admission for ICU-level care, or IV inotropic/vasopressor therapy for ADHF.
- Na+ <125 mmol/L or Na+ >145 mmol/L.
- End-stage chronic kidney disease on chronic dialysis or eGFR <15 mL/min/1.73 m2
- Any condition which would make participation unsafe or substantially affect protocol adherence, as judged by investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology, Gødstrup Hospital
Herning, 7400
Anders Hostrup Larsen, MD, PhD, 0045, anders.hostrup@rm.dk
About this study
Official title: Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure: a Randomized Trial
The aim of this clinical trial is to learn whether a thirst-driven, liberal fluid-intake strategy is comparable to a fluid-restriction strategy in patients hospitalized for acute decompensated heart failure (ADHF). The study will also assess the safety of the intervention and its effects on thirst and quality of life.
Patients hospitalized with ADHF will be asked to follow either a thirst-driven fluid-intake strategy or a fluid-restriction strategy during their hospital stay and for one month after discharge.
- Conditions
- Acute Heart Failure (AHF)
- Being tested
- Fluid restriction strategy, Thirst-driven, liberal fluid intake
- Keywords
- Fluid Restriction, Thirst-driven fluid intake, Liberal fluid intake, Acute heart failure, Time to clinical stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid restriction strategyBehavioural
Fluid restriction of 1.5 L/day
Thirst-driven, liberal fluid intakeBehavioural
Liberal fluid intake driven by thirst without restrictions
| Study group | Role | What they receive |
|---|---|---|
| Thirst-driven, liberal fluid intake | Experimental | Not described Receives: Behavioral: Thirst-driven, liberal fluid intake |
| Fluid restriction | Active comparator | Not described Receives: Behavioral: Fluid restriction strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical stability
Time from randomization to clinical stability. Clinical stability is defined as:
- Off IV loop diuretics for ≥ 24 hours without need for reinitiation of IV diuretics.
- No evidence of pulmonary congestion, defined as both:
- No new or worsening dyspnea at rest compared with status at admission ii) Clear lung auscultation or clinically improved, or normal lung and/or vena cava ultrasound without evidence of congestion.
- No new or worsening peripheral edema compared with status at admission.
Measured: From enrollment to 1 month follow-up
Secondary outcomes (3)
Thirst Distress
Thirst Distress Scale for patients with Heart Failure (TDS-HF). Scores range from 8 to 40. Higher scores indicate greater thirst-related distress
Measured: From enrollment to 1 month follow up
Patient-perceived Quality of Life
Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100, with higher scores indicating better health status.
Measured: From enrollment to 1 month follow up
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of occurrences during hospitalization of clinical worsening (escalation of HF therapy, such as vasopressor/inotrope initiation, ICU transfer, dialysis, reinitiation of IV diuretics), electrolyte disturbances, worsening renal function, or in-hospital death, and similarly after one month including HF hospitalization
Measured: From enrollment to 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 May 2026
- Primary completion1 May 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400991
- Sponsor's protocol ID
- 1-16-02-56-26
- Acronym
- RELIEF-AHF
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to regulations by Region Committees on Health Research Ethics
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure: a Randomized Trial
- ClinicalTrials.gov ID
- NCT07400991
- Acronym / sponsor ID
- RELIEF-AHF / 1-16-02-56-26
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- Fluid Restriction, Thirst-driven fluid intake, Liberal fluid intake, Acute heart failure, Time to clinical stability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 10 Feb 2026 (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.
The aim of this clinical trial is to learn whether a thirst-driven, liberal fluid-intake strategy is comparable to a fluid-restriction strategy in patients hospitalized for acute decompensated heart failure (ADHF). The study will also assess the safety of the intervention and its effects on thirst and quality of life.
Patients hospitalized with ADHF will be asked to follow either a thirst-driven fluid-intake strategy or a fluid-restriction strategy during their hospital stay and for one month after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thirst-driven, liberal fluid intake | Experimental | Behavioral: Thirst-driven, liberal fluid intake |
| Fluid restriction | Active comparator | Behavioral: Fluid restriction strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years
- Hospitalized for ADHF as the primary diagnosis, meeting both of the following:
- Treatment with ≥40 mg IV furosemide (or equivalent)
- Enrolment within 24 hours of admission
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Requirement at admission for ICU-level care, or IV inotropic/vasopressor therapy for ADHF.
- Na+ <125 mmol/L or Na+ >145 mmol/L.
- End-stage chronic kidney disease on chronic dialysis or eGFR <15 mL/min/1.73 m2
- Any condition which would make participation unsafe or substantially affect protocol adherence, as judged by 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 restriction strategyFluid restriction of 1.5 L/day | Behavioural | Fluid restriction |
| Thirst-driven, liberal fluid intakeLiberal fluid intake driven by thirst without restrictions | Behavioural | Thirst-driven, liberal fluid intake |
Primary outcome
Time to clinical stability
Time frame: From enrollment to 1 month follow-up
Time from randomization to clinical stability. Clinical stability is defined as: 1. Off IV loop diuretics for ≥ 24 hours without need for reinitiation of IV diuretics. 2. No evidence of pulmonary congestion, defined as both: i) No new or worsening dyspnea at rest compared with status at admission ii) Clear lung auscultation or clinically improved, or normal lung and/or vena cava ultrasound without evidence of congestion. 3. No new or worsening peripheral edema compared with status at admission.
3 secondary outcomes
Thirst Distress
Time frame: From enrollment to 1 month follow up
Patient-perceived Quality of Life
Time frame: From enrollment to 1 month follow up
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: From enrollment to 1 month follow up
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 7 May 2026.
- Individual participant dataSharing planned: Undecided. Due to regulations by Region Committees on Health Research Ethics
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid restriction strategy and Thirst-driven, liberal fluid intake in people with Acute Heart Failure (AHF), run by Gødstrup Hospital at 1 site 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 8 inclusion and 4 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 7 May 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 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?
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 Anders Hostrup Larsen, MD, PhD (0045, anders.hostrup@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical stability (time frame: From enrollment to 1 month follow-up). 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 7 May 2026.