Congestion profiles in adults hospitalized with acute heart failure
a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart
University Medical Center Groningen · NCT06587854
This project will see if different congestion types in adults hospitalized with acute heart failure predict response to IV loop diuretics and risks of rehospitalization or death.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06587854 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling 270 adults admitted with acute heart failure who require intravenous loop diuretics. Participants will undergo bedside assessments including ultrasound of filling pressures, lungs, and kidneys, liver Fibroscan, and sublingual sidestream darkfield imaging, with additional biomarker substudies (GLYCO-AHF and PREACH-AHF). The primary aim is to identify distinct congestion phenotypes and link them to 24-hour natriuresis and the composite outcome of all-cause mortality or heart failure rehospitalization at 6 months. Exploratory outcomes include length of hospital stay, congestion at discharge, and changes in filling pressures over time.
Who should consider this trial
Good fit: Adults (≥18 years) admitted with a primary diagnosis of acute heart failure who require intravenous loop diuretics and can give informed consent are ideal candidates.
Not a fit: Patients on dialysis or ultrafiltration, those with dyspnea or edema due primarily to non-cardiac causes, or those unable to comply with study procedures are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, identifying congestion phenotypes could help clinicians tailor decongestion strategies to improve fluid removal and reduce rehospitalizations.
How similar studies have performed: Previous observational work has suggested distinct congestion patterns relate to outcomes, but using these patterns to guide therapy and predict diuretic response is still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Groningen
- UMCG — Groningen, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Jozine M. ter Maaten, MD, PhD
- Email: j.m.ter.maaten@umcg.nl
- Phone: +31503616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Heart Failure