Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT03200860
Eligibility Criteria:
Inclusion Criteria:
* Male or female \>18 years of age; Women of non-child-bearing potential must have a documentation of surgical sterilization (hysterectomy and/or bilateral oophorectomy) OR must have experienced menopause (no menses for \>12 months). Women of child bearing potential must have a negative pregnancy test, AND must use highly effective methods of contraception during treatment with IP plus 5 days after the end of study drug administration.
* Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
1. Dyspnea at rest or with minimal exertion
2. Signs of congestion, such as edema, rales, and/or congestion on chest radiograph
3. BNP ≥350 pg/mL or NT-proBNP ≥1,400 pg/mL (for patients with AF: BNP≥500 pg/mL or NT-proBNP ≥2,000 pg/mL)
4. Treated with loop diuretics at screening
* Able to be randomized within 24 hours from presentation to the hospital
* Able and willing to provide freely given written informed consent
* eGFR (CKD-EPI) ≥30 ml/min/1.73m2 between presentation and randomization
Exclusion Criteria:
* Diabetes Mellitus Type I
* Dyspnea primarily due to non-cardiac causes
* Cardiogenic shock
* Acute coronary syndrome within 30 days prior to randomization
* Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
* Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH\>7.30 and glucose \>15 mmol/L and HCO3\>18 mmol/L)
* Pregnant or nursing (lactating) women
* Current participation in any interventional study
* Inability to follow instructions or comply with follow-up procedures
* Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03200860
Study Brief:
Protocol Section:
NCT03200860