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:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT02644057
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 years
2. Admitted to the hospital with a primary diagnosis of Decompensated Heart Failure
3. Onset of cardio-renal syndrome (increasing creatinine\>0.3mg/dl) after or before hospitalization. After hospitalization within 7 days of from the time of admission after receiving intravenous diuretics and heart failure medication optimization. Before hospitalization in the setting of escalating doses of outpatient loop diuretics and heart failure medication optimization
4. Persistent volume overload- For patients with a pulmonary artery catheter, peristent volume overload will include :
Pulmonary capillary wedge pressure \>22mm Hg and one of the following clinical signs :2+ peripheral edema and/or pulmonary edema or pleural effusion on chest Xray. For patients without a pulmonary artery catheter- persistent volume overload will include atleast 2 of the following: 2+ peripheral edema , jugular venous pressure \>10 mm Hg and pulmonary edema or pleural effusion on chest Xray
5. BNP\>400
6. Cr-1.2-3.0
Exclusion Criteria:
1. Intravascular volume depletion
2. Acute coronary syndrome within 4 weeks
3. Indication for hemodialysis
4. Systolic Blood pressure \<90mm Hg or MAP\<60mm Hg at the time of enrollment
5. Alternate explanation for worsening renal function , such as obstructive nephropathy , contrast induced nephropathy , ATN
6. Clinical instability likely to require the addition of intravenous vasoactive drugs including vasodilators and/or inotropic drugs
7. The use of iodinated radio-contrast material in the past 72 hours or anticipated use of intravenous contrast during the current hospitalization
8. Underlying rhythm disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT02644057
Study Brief:
Protocol Section:
NCT02644057