Acute Decompensated Heart FailureNCT04877652
DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
An observational study of Acute Decompensated Heart Failure, run by Revamp Medical Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- How many people
- 6 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Nov 2021to 25 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Heart Failure Patients with Insufficient Response to Diuretics
Who may be able to join
- 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
Show all 10Show fewer
- enlarged liver or ascites
- pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
- Jugular venous distention > 7 cmH2O
- Subject insufficiently responds to IV diuretic therapy
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Weill Cornell
New York, New York, 10021
Columbia University Irving Medical Center
New York, New York, 10032
Montefiore Medical Center - Moses Campus
New York, New York, 10461
St Francis Hospital
New York, New York, 11576
About this study
Official title: 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.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Standard of care
- Keywords
- ADHF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Standard medical treatment of ADHF patients deemed to have insufficient diuretic response.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
SAEs (including MACE) post enrollment based on CEC adjudication.
Measured: 30 days
Serum Creatinine
Change in level
Measured: Baseline [T=0] and 48 hours
Urine Output
Change in the rate
Measured: Baseline [T=0-12h] and through 24 hours [T=12-36h]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start17 Nov 2021
- Primary completion20 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revamp Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877652
- Sponsor's protocol ID
- CIS-D-02
- Status last verified
- May 2022
- First submitted
- 19 Apr 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DR REGISTRY: Prospective Observational Study of Decongestion in Acute Heart Failure Patients With Insufficient Response to Diuretics
- ClinicalTrials.gov ID
- NCT04877652
- Acronym / sponsor ID
- CIS-D-02
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- ADHF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Revamp Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHF patients | – | Other: Standard of carePatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Heart Failure Patients with Insufficient Response to Diuretics
Key inclusion criteria (10 listed)
- 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:
- Subject insufficiently responds to IV diuretic therapy
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careStandard medical treatment of ADHF patients deemed to have insufficient diuretic response. | Other | ADHF patients |
Primary outcome
Serious Adverse Events
Time frame: 30 days
SAEs (including MACE) post enrollment based on CEC adjudication.
Serum Creatinine
Time frame: Baseline [T=0] and 48 hours
Change in level
Urine Output
Time frame: Baseline [T=0-12h] and through 24 hours [T=12-36h]
Change in the rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by Revamp Medical Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.