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Completed

NCT Number: NCT04877652

DR REGISTRY: Prospective Observational Study of ADHF 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Standard of care

Other

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

Primary outcomes

  1. Serious Adverse Events

    Time frame: 30 days

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

  2. Serum Creatinine

    Time frame: Baseline [T=0] and 48 hours

    Change in level

  3. Urine Output

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

    Change in the rate

Other outcomes

  1. 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)

  2. Peripheral Edema

    Time frame: Baseline [T=0] and 48 hours

    Change in score (ranges from none/0 to +4)

  3. Length of hospitalization

    Time frame: through follow-up period completion (up to 60 days)

    Length of current hospitalization (resolution of acute heart failure condition)

  4. Heart Failure Readmission

    Time frame: Baseline through 30 days

    Time to readmission due to HF, up to 30 days

Sponsors and collaborators

Lead sponsor

Revamp Medical Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 7, 2021
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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