Overview
Sponsor-declared trial summary
Acute heart failure with volume overload
To determine if there is a difference in the diuretic treatment effect in acute heart failure between intravenous administration of furosemide by either continuous infusion preceded by a loading dose or bolus injections three times a day.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2026-04-24
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Randers Regional Hospital · Health Research Foundation of Central Denmark Region · Department of Clinical Medicine, Aarhus University · Grosserer L. F. Foghts Fond
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To determine if there is a difference in the diuretic treatment effect in acute heart failure between intravenous administration of furosemide by either continuous infusion preceded by a loading dose or bolus injections three times a day.
Conditions and MedDRA coding
Acute heart failure with volume overload
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Inclusion phase Starting from identifying a study subject during hospitalisation until either continuous infusion with a loading dose or bolus injections are administered (first injection).
|
Not Applicable | None | ||
| 2 | Treatment phase Starting from the first injection until the last weight measurement on the morning of Day 4.
|
Randomised Controlled | None | Infusion: Intravenous furosemide as continuous infusion with a loading dose Bolus: Intravenous furosemide as bolus injections three times a day |
|
| 3 | Follow-up phase Starting from when the treatment phase ends until 30 days after the first injection.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Clinical diagnosis of acute heart failure with volume overload
- ≥ 1 sign of volume overload
- Anticipated intravenous furosemide ≥ 3 days
- Age ≥ 18 years
Exclusion criteria 7
- Shock
- Patient requiring treatment with inotropes or vasopressors
- Current or planned use of renal replacement therapy or ultrafiltration
- Patient with a renal transplant
- Patients who are pregnant or breastfeeding
- Severe hypokalaemia (<2.5 mmol/L) or severe hyponatremia (<125 mmol/L)
- Allergy to furosemide and its components
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Net weight loss 3 days (≈72 hours) after randomisation
Secondary endpoints 4
- Net weight loss 2 days (≈48 hours) after randomisation
- Change in dyspnea on a Visual Analogue Scale 3 days (≈72 hours) after randomisation
- Days alive out-of-hospital to Day 30
- Length of stay
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP106369633 · ATC
- Active substance
- Amiloride Hydrochloride
- Substance synonyms
- 3,5-DIAMINO-6-CHLORO-N-(DIAMINOMETHYLIDENE)PYRAZINE-2-CARBOXAMIDE HYDROCHLORIDE
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- C03CA01 — FUROSEMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Skovlyvej 15
- City
- Randers Noe
- Postcode
- 8930
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Esben Merrild
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Esben Merrild
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 8, Code 9 |
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 436 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523589-26 | 2 |
| Protocol (for publication) | D4_Patient facing documents Dyspnea_VAS_2025-523589-26 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF DK | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC furosemide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DK 2025-523589-26 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-27 | Denmark | Acceptable 2026-04-22
|
2026-04-24 |