DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics

Acute Decompensated Heart Failure Clinical Trial

Official title:

DR REGISTRY: Prospective Observational Study of Decongestion in Acute Heart Failure Patients With Insufficient Response to Diuretics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877652
• Other study ID #: CIS-D-02
• Status: Completed
• Start date: November 17, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: May 2022
• Source: Revamp Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 25, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Subject is >18 and < 85 years of age.

2. Subject is hospitalized with primary diagnosis of ADHF.

3. N-terminal-pro-brain natriuretic peptide (NT-proBNP) =1,600 pg/m or BNP=400 pg/mL.

4. Evidence of fluid overload as indicated by 2 or more of the following criteria:

1. peripheral edema = 2+

2. radiographic pulmonary edema or pleural effusion

3. enlarged liver or ascites

4. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea

5. Jugular venous distention > 7 cmH2O

5. Subject insufficiently responds to IV diuretic therapy

Exclusion Criteria:

1. Systolic blood pressure <90 mmHg at the time of screening.

2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleural synthesis within past 7 days or cardiovascular intervention within past 4 days.

3. Known LVEF < 15% by echocardiography within 1 year prior to enrolment.

4. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).

5. Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade.

6. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention.

7. Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite > 48 hours of antibiotic treatment).

8. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Other:
• Standard of care
Standard medical treatment of ADHF patients deemed to have insufficient diuretic response.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York
United States	Montefiore Medical Center - Moses Campus	New York	New York
United States	St Francis Hospital	New York	New York
United States	Weill Cornell	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Revamp Medical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dyspnea	Change in dyspnea score using the Likert scale (score ranges from -3 to +3, higher score means better improvement)	Baseline [T=0] and 48 hours
Other	Peripheral Edema	Change in score (ranges from none/0 to +4)	Baseline [T=0] and 48 hours
Other	Length of hospitalization	Length of current hospitalization (resolution of acute heart failure condition)	through follow-up period completion (up to 60 days)
Other	Heart Failure Readmission	Time to readmission due to HF, up to 30 days	Baseline through 30 days
Primary	Serious Adverse Events	SAEs (including MACE) post enrollment based on CEC adjudication.	30 days
Primary	Serum Creatinine	Change in level	Baseline [T=0] and 48 hours
Primary	Urine Output	Change in the rate	Baseline [T=0-12h] and through 24 hours [T=12-36h]