DR REGISTRY: Prospective Observational Study of Decongestion in Acute Heart Failure Patients With Insufficient Response to Diuretics
Status: Completed
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
The study objective is to observe and measure clinical outcomes, urine output, and safety events occurring during standard medical treatment of ADHF patients deemed to have insufficient diuretic response.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Subject is \>18 and \< 85 years of age.
• Subject is hospitalized with primary diagnosis of ADHF.
• N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/m or BNP≥400 pg/mL.
• Evidence of fluid overload as indicated by 2 or more of the following criteria:
‣ peripheral edema ≥ 2+
⁃ radiographic pulmonary edema or pleural effusion
⁃ enlarged liver or ascites
⁃ pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
⁃ Jugular venous distention \> 7 cmH2O
• Subject insufficiently responds to IV diuretic therapy
Locations
United States
New York
Columbia University Irving Medical Center
New York
Montefiore Medical Center - Moses Campus
New York
St Francis Hospital
New York
Weill Cornell
New York
Time Frame
Start Date: 2021-11-17
Completion Date: 2022-05-25
Participants
Target number of participants: 6
Treatments
ADHF patients
Patients with acute decompensated heart failure (ADHF) having insufficient response to diuretic therapy following a dose escalation protocol in keeping with AHA guidelines for the management of heart failure.
Authors
Daniel Sims, David Majure, Noah Moss, Shudhanshu Alishetti, Gabriel Sayer, Rita Jermyn, Parag Goyal, Justin Fried, Aman Shah, Kumudha Ramasubbu
Related Therapeutic Areas
Sponsors
Leads: Revamp Medical Ltd.