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

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Other: Standard of care

• Registration Number: NCT04877652
• Lead Sponsor: Revamp Medical Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-07
• Study Start: 2021-11-17
• Status Verified: 2022-05
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-25
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADHF patients	Standard of care	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.

Primary Outcome Measures

Name	Time	Method
Serum Creatinine	Baseline [T=0] and 48 hours	Change in level
Serious Adverse Events	30 days	SAEs (including MACE) post enrollment based on CEC adjudication.
Urine Output	Baseline [T=0-12h] and through 24 hours [T=12-36h]	Change in the rate

Trial Locations

Locations (4)

Montefiore Medical Center - Moses Campus; 🇺🇸 New York, New York, United States

Weill Cornell; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

St Francis Hospital; 🇺🇸 New York, New York, United States