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

NCT ID: NCT04877652

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2022-05-25

Brief 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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Standard of care

Intervention Type: OTHER

Standard medical treatment of ADHF patients deemed to have insufficient diuretic response.

Interventions

Standard of care

Standard medical treatment of ADHF patients deemed to have insufficient diuretic response.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revamp Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Weill Cornell

New York, New York, 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

Countries

United States

Other Identifiers

CIS-D-02

Identifier Type: -

Identifier Source: org_study_id