Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
30
Countries
1
Sites
1
Acute Heart Failure
Improvement in natriuresis
Key facts
- Sponsor
- Ziekenhuis Oost Limburg
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-01-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513799-16-00
- EudraCT number
- 2023-000167-31
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Improvement in natriuresis
Secondary objectives 3
- Improvement in diuresis
- Changes in different indices of congestion
- Weight change
Conditions and MedDRA coding
Acute Heart Failure
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 18 years or older
- Heart Failure
- Maintenance therapy with loop diuretics of at least 40mg of furosemide or equivalents
- Deemed volume overloaded by treating cardiologist warranting the addition of SGLT2i and IV loop diuretic therapy
Exclusion criteria 3
- Kidney function impairment with an eGFR <20ml/min/1.73m² (result within last 6 months)
- Inability to collect 24h urine collections
- Systolic blood pressure below 90mmHg
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 24-hour sodium excretion
Secondary endpoints 6
- 24-hour volume output
- Weight change
- Congestion assessment according to the ADVOR protocol
- Plasma volume changes
- Changes in neurohormonal stimulation (renin, aldosterone)
- Changes in POCUS (Heart, IVC, lung, abdomen, JVP)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
DIAMOX parenteraal 500 mg poeder voor injectievloeistof
PRD1167631 · Product
- Active substance
- Acetazolamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01EC01 — ACETAZOLAMIDE
- Marketing authorisation
- RVG 00644
- MA holder
- AMDIPHARM LIMITED
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Jardiance 10 mg film-coated tablets
PRD1594848 · Product
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — -
- Marketing authorisation
- EU/1/14/930/010
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Forxiga 10 mg film-coated tablets
PRD2427550 · Product
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — -
- Marketing authorisation
- EU/1/12/795/009
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ziekenhuis Oost Limburg
- Sponsor organisation
- Ziekenhuis Oost Limburg
- Address
- Synaps Park 1
- City
- Genk
- Postcode
- 3600
- Country
- Belgium
Scientific contact point
- Organisation
- Ziekenhuis Oost Limburg
- Contact name
- Clinical Trial Unit
Public contact point
- Organisation
- Ziekenhuis Oost Limburg
- Contact name
- Clinical Trial Unit
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 30 | 1 |
| 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 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | IFC_COMBO-HF Finaal | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_acetazolamide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_dapagliflozine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_jardiance | 1 |
| Synopsis of the protocol (for publication) | PROTOCOL-SUMMARY | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-17 | Belgium | Acceptable 2025-01-15
|
2025-01-15 |