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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01733134
Eligibility Criteria:
Inclusion Criteria:
1. Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure
2. Dyspnea at rest or minimal exertion per the patient
3. Evidence of extracellular volume expansion by at least one of the following: JVD, Rales, Ascites, Edema or positive Chest X-ray defined as cardiomegaly, pulmonary vascular congestion, Kerley B-lines, pulmonary edema and/or pleural effusion.
4. Elevated BNP level \>200 pg/ml, or NTproBNP \> 1000pg/mL
5. Able to administer study drug within 8 hours from triage time
Inpatient Hospitalized Inclusion Only:
Co-peptin level \> 27 pmol/L
Exclusion Criteria:
1. Unable to provide informed consent
2. Unable to have 30 day telephone follow up
3. Not expected to survive past 6 months
4. On Renal replacement therapy or creatinine \>3.5
5. History of allergy or intolerance to Tolvaptan
6. Suspected Pregnancy
7. Cardiogenic Shock
8. Participation in any interventional trial in prior 30 days.
9. Receiving or planned to receive IV Inotropic therapy
10. ACS now or in the past 30 days
11. Treatment with IV infusion vasoactive drugs in the hour prior to enrollment
12. Temperature \> 100.5
13. Heart Failure due to atrial fibrillation with Rapid Ventricular Response
14. SBP \< 90 mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01733134
Study Brief:
Protocol Section:
NCT01733134