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

NCT04877652 | Completed

• 1 other identifier: CIS-D-02
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 4

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

Keywords

ADHF

Outcome Measures

Primary Outcomes (3)

• Serious Adverse Events

  SAEs (including MACE) post enrollment based on CEC adjudication.

  30 days

• Serum Creatinine

  Change in level

  Baseline [T=0] and 48 hours

• Urine Output

  Change in the rate

  Baseline [T=0-12h] and through 24 hours [T=12-36h]

Other Outcomes (4)

• Dyspnea

  Baseline [T=0] and 48 hours

• Peripheral Edema

  Baseline [T=0] and 48 hours

• Length of hospitalization

  through follow-up period completion (up to 60 days)

Study Arms (1)

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.

Other: Standard of care

Interventions

Standard of care OTHER

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

ADHF patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Heart Failure Patients with Insufficient Response to Diuretics

You may qualify if:

• 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

You may not qualify if:

• Systolic blood pressure \<90 mmHg at the time of screening.
• Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleural synthesis within past 7 days or cardiovascular intervention within past 4 days.
• Known LVEF \< 15% by echocardiography within 1 year prior to enrolment.
• Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
• Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade.
• Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
• 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).
• Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Sponsors & Collaborators

• Revamp Medical Ltd.: lead

Study Sites (4)

Weill Cornell

New York, New York, 10021, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center - Moses Campus

New York, New York, 10461, United States

Location

St Francis Hospital

New York, New York, 11576, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 7, 2021
• Study Start: November 17, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 25, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

US (4)