- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04877652
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
Conditions
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
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-
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:
- 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.
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.
Sponsor
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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