Acute Heart FailurePROFILE-AHFNCT06587854
a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart Failure
An observational study of Acute Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The goal of this observational is to study the prevalence of distinct congestion phenotypes and study their association with response to therapy and outcomes in acute heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- How many people
- 270 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2025to 31 Dec 2029
- Phase
- Observational
- 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
Study population: Adult patients admitted to the hospital with a primary diagnosis of acute heart failure
Who may be able to join
- Able and willing to give written informed consent
- Age ≥ 18 years
- Male or female
- Primary diagnosis of acute heart failure at presentation, with signs and symptoms of tissue decongestion. Diagnosis is based on the criteria in the ESC HF guidelines (1)
- Requirement of intravenous loop diuretics
Who cannot join
- Patients with severe kidney dysfunction (in need for ultrafiltration or dialysis)
- Previous participation in this study
- Inability to follow instructions
- Dyspnoea or oedema primarily due to non-cardiac causes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lara E.E.C. Zonneveld, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen
Lara E.E.C. Zonneveld, MD, +31503616161, l.e.e.c.zonneveld@umcg.nl
About this study
Official title: a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart
The goal of this observational is to study the prevalence of distinct congestion phenotypes and study their association with response to therapy and outcomes in acute heart failure patients. The main question[s] it aims to answer [is/are]:
- Primary objective: to study the prevalence of distinct congestion phenotypes
- Other objectives (including):
- Response to therapy as assessed by
- Natriuresis after 24 hours
- Rehospitalization and/or deats after 6 months
- Length of hospital stay
- Congestion at discharge
- Changes in filling pressures over time
- Relationship between liver stiffness, as assessed with Fibroscan and congestion
- Substudy: glycosaminoglycan netword and endothial glycocalyx
Read more
Participants will undergo several extra study related measurements:
- Assessment of filling pressures with ultrasound
- Ultrasound investigation of the lungs and kidneys
- Fibroscan of the liver
- Sidestream darkfield imaging sublingual
- As part of substudy GLYCO-AHF: skin biopsy to determine glycocalyx, as well as salt and water content.
- As part of substudy PREACH-AHF: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins
Read the detailed description
Objective: to study the prevalence of distinct congestion phenotypes and investigate their association with response to therapy and outcomes in acute heart failure patients.
Study design: Observational, prospective study
Study population: 270 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.
Main study parameters/endpoints:
To identify distinct congestion phenotypes and study their association with response to therapy and outcomes
Secondary outcomes: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Exploratory outcomes include: length of hospital stay, congestion at discharge and changes in filling pressures over time. Furthermore, as part of the GLYCO-AHF substudy: the expression of glycosaminoglycans and, as part of the PREACH-AHF substudy: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins.
- Conditions
- Acute Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the prevalence of distinct congestion phenotypes
Based on the degree of congestion and edema in combination with intravascular pressures, patients will be classified into different phenotypes (high/low intravascular pressures and extensive/minimal edema.
Measured: From date of hospital admission untill the date of discharge (from this admission), with an expected discharge after 5 to 10 days after admission.
Secondary outcomes (2)
Total natriuresis after 24 hours
To assess this, urine is collected for 24 hours after the first administration of diuretics according to the hospital protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).with natriuresis as the primary outcome measure.
Measured: 24 hours
Rehospitalization and/or death after 6 months
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 May 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 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 FailureStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jozine ter Maaten, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587854
- Sponsor's protocol ID
- 20486
- Acronym
- PROFILE-AHF
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2024
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart
- ClinicalTrials.gov ID
- NCT06587854
- Acronym / sponsor ID
- PROFILE-AHF / 20486
- Conditions
- Acute Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this observational is to study the prevalence of distinct congestion phenotypes and study their association with response to therapy and outcomes in acute heart failure patients. The main question[s] it aims to answer [is/are]:
- Primary objective: to study the prevalence of distinct congestion phenotypes
- Other objectives (including):
- Response to therapy as assessed by
- Natriuresis after 24 hours
- Rehospitalization and/or deats after 6 months
- Length of hospital stay
- Congestion at discharge
- Changes in filling pressures over time
- Relationship between liver stiffness, as assessed with Fibroscan and congestion
- Substudy: glycosaminoglycan netword and endothial glycocalyx
Participants will undergo several extra study related measurements:
- Assessment of filling pressures with ultrasound
- Ultrasound investigation of the lungs and kidneys
- Fibroscan of the liver
- Sidestream darkfield imaging sublingual
- As part of substudy GLYCO-AHF: skin biopsy to determine glycocalyx, as well as salt and water content.
- As part of substudy PREACH-AHF: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins
Detailed description
Objective: to study the prevalence of distinct congestion phenotypes and investigate their association with response to therapy and outcomes in acute heart failure patients.
Study design: Observational, prospective study
Study population: 270 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.
Main study parameters/endpoints:
To identify distinct congestion phenotypes and study their association with response to therapy and outcomes
Secondary outcomes: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Exploratory outcomes include: length of hospital stay, congestion at discharge and changes in filling pressures over time. Furthermore, as part of the GLYCO-AHF substudy: the expression of glycosaminoglycans and, as part of the PREACH-AHF substudy: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the hospital with a primary diagnosis of acute heart failure
Key inclusion criteria (5 listed)
- Able and willing to give written informed consent
- Age ≥ 18 years
- Male or female
- Primary diagnosis of acute heart failure at presentation, with signs and symptoms of tissue decongestion. Diagnosis is based on the criteria in the ESC HF guidelines (1)
- Requirement of intravenous loop diuretics
Key exclusion criteria (4 listed)
- Patients with severe kidney dysfunction (in need for ultrafiltration or dialysis)
- Previous participation in this study
- Inability to follow instructions
- Dyspnoea or oedema primarily due to non-cardiac causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To study the prevalence of distinct congestion phenotypes
Time frame: From date of hospital admission untill the date of discharge (from this admission), with an expected discharge after 5 to 10 days after admission.
Based on the degree of congestion and edema in combination with intravascular pressures, patients will be classified into different phenotypes (high/low intravascular pressures and extensive/minimal edema.
2 secondary outcomes
Total natriuresis after 24 hours
Time frame: 24 hours
Rehospitalization and/or death after 6 months
Time frame: 180 days
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 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Lara E.E.C. Zonneveld, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 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 10 Sep 2025. 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 Netherlands. 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 Jozine M. ter Maaten, MD, PhD (+31503616161, j.m.ter.maaten@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the prevalence of distinct congestion phenotypes (time frame: From date of hospital admission untill the date of discharge (from this admission), with an expected discharge after 5 to 10 days after admission.). 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 10 Sep 2025.