Clinical trial • Cardiology

Dapagliflozin for Acute heart failure

Clinical trial of Dapagliflozin for Acute heart failure. 30 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Acute heart failure
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-12-2024
First CTIS Authorization Date
15-01-2025

Trial design

Clinical trial across 1 site in Belgium.

Target Sample Size
30

Eligibility

Recruits 30 Vulnerable populations not selected; participants are adults (minimum age 18). No additional consent/assent handling information provided in the record..

Vulnerable Population
Vulnerable populations not selected; participants are adults (minimum age 18). No additional consent/assent handling information provided in the record.

Inclusion criteria

  • {"criterion_text":"- 18 years or older"}
  • {"criterion_text":"- Heart Failure"}
  • {"criterion_text":"- Maintenance therapy with loop diuretics of at least 40mg of furosemide or equivalents"}
  • {"criterion_text":"- Deemed volume overloaded by treating cardiologist warranting the addition of SGLT2i and IV loop diuretic therapy"}

Exclusion criteria

  • {"criterion_text":"- Kidney function impairment with an eGFR <20ml/min/1.73m² (result within last 6 months)"}
  • {"criterion_text":"- Inability to collect 24h urine collections"}
  • {"criterion_text":"- Systolic blood pressure below 90mmHg"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 24-hour sodium excretion","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 24-hour volume output","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Weight change","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Congestion assessment according to the ADVOR protocol","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Plasma volume changes","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Changes in neurohormonal stimulation (renin, aldosterone)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Changes in POCUS (Heart, IVC, lung, abdomen, JVP)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
30
Recruitment Window Months
23
Consent Approach
Subject information and informed consent form document is listed (IFC_COMBO-HF Finaal) but the record does not provide details on the consent process, who provides consent, assent procedures, age-specific documents, or languages available.

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Belgium

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
15-01-2025
Processing Time Days
2
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
Cardiology
Contact Person Name
Wilfried Mullens
Contact Person Email
wilfried.mullens@zol.be
Number Of Participants
30

Sponsor

Primary sponsor

Full Name
Ziekenhuis Oost Limburg
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
Forxiga 10 mg film-coated tablets
Active Substance
Dapagliflozin
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketed/authorised (marketing authorisation present)
Maximum Dose
10 mg
Investigational Product Name
Jardiance 10 mg film-coated tablets
Active Substance
Empagliflozin
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketed/authorised (marketing authorisation present)
Maximum Dose
10 mg
Investigational Product Name
DIAMOX parenteraal 500 mg poeder voor injectievloeistof
Active Substance
Acetazolamide
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketed/authorised (marketing authorisation present)
Maximum Dose
500 mg
Combination Treatment
Yes

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