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

May 25, 2022 updated by: Revamp Medical Ltd.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell
      • New York, New York, United States, 10461
        • Montefiore Medical Center - Moses Campus
      • New York, New York, United States, 11576
        • St Francis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute Heart Failure Patients with Insufficient Response to Diuretics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 medical treatment of ADHF patients deemed to have insufficient diuretic response.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: Baseline [T=0] and 48 hours
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
Peripheral Edema
Time Frame: Baseline [T=0] and 48 hours
Change in score (ranges from none/0 to +4)
Baseline [T=0] and 48 hours
Length of hospitalization
Time Frame: through follow-up period completion (up to 60 days)
Length of current hospitalization (resolution of acute heart failure condition)
through follow-up period completion (up to 60 days)
Heart Failure Readmission
Time Frame: Baseline through 30 days
Time to readmission due to HF, up to 30 days
Baseline through 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

May 25, 2022

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIS-D-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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