Acute Decompensated Heart FailurePhase 2BLAST-AHFNCT01966601
A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
A Phase 2 study testing TRV027 Dose #1, TRV027 Dose #2 and TRV027 Dose #3 in people with Acute Decompensated Heart Failure, run by Trevena Inc. at 62 sites in 12 countries.
Trial summary
To evaluate the overall safety and efficacy of TRV027 when administered in addition to standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients hospitalized with Acute Decompensated Heart Failure (ADHF). Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- TRV027 Dose #1, TRV027 Dose #2 and TRV027 Dose #3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- 62 sitesin 12 countries
- Study dates
- Dec 2013to Sep 2016
- Phase
- Phase 2
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged ≥21 years and ≤ 85 years 1a.Women of non-child-bearing potential
- Able to provide written informed consent
- Pre-existing diagnosis of heart failure and at least 30 days treatment with daily oral loop diuretics
- Systolic blood pressure ≥105 mmHg and ≤ 160 mmHg within 30 minutes of randomization
- Ventricular rate ≤125 bpm. Patients with rate-controlled persistent or permanent atrial fibrillation (aFib) at screening are permitted.
- Presence of ADHF defined by:
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- BNP > 400 pg/mL or NT-proBNP > 1600 pg/mL
- For patients with BMI >30 kg/m2: BNP > 200 pg/mL or NT-proBNP > 800 pg/mL
- For patients with rate-controlled persistent or permanent aFib: BNP > 600 pg/mL or NT-proBNP > 2400 pg/mL
- Congestion on chest radiograph (CXR)
- AND at least two (2) of the following:
- Rales by chest auscultation
- Edema ≥ +1 on a 0-3 + scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any dependent area including extremities or sacral region.
- Elevated jugular venous pressure (≥8 cm H2O)
- Receipt of a IV loop diuretic at a minimum dose 40 mg furosemide (or equivalent loop diuretic) for the treatment of dyspnea due to ADHF at least 1 hour prior to anticipated randomization and the initiation of study medication
- Patient report of dyspnea at rest or upon minimal exertion during screening at least one hour after administration of IV loop diuretic
Who cannot join
- Women who are pregnant or breast-feeding
- Clinical presentation:
- Suspected ACS based on clinical judgment
- Coronary revascularization in the 3 months prior to screening or planned during current admission.
- Temperature >38.5oC
- Clinically significant anemia
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- Serum sodium >145 mEq/L (145 mmol/L)
- Current or planned ultrafiltration, paracentesis, hemofiltration or dialysis at time of screening
- Any mechanical ventilation
- CPAP/BiPAP discontinued less than 1 hour prior to randomization
- History of LVAD or IABP within the last year
- Intravenous radiographic contrast agent within 72 hours prior to screening or presence of acute contrast induced nephropathy at the time of screening
- Presence of clinically significant arrhythmia
- Uncertainty of ability to complete follow up
- Medications:
- nitroprusside or nesiritide
- Intravenous nitrates
- use of inotropes
- Use of ARBs within 7 days of prior to randomization
- Use of any investigational medication within 30 days
- clinically significant hypersensitivity or allergy to, or intolerance of, angiotensin receptor blockers
- Medical history:
- Major surgery within 8 weeks prior to screening
- Stroke within 3 months prior to screening
- eGFR (sMDRD) <20 mL/min/1.73m2 or >75 mL/min/1.73m2 between presentation and randomization
- Post cardiac or renal transplant
- Listed for renal transplant or cardiac transplant with anticipated transplant time to transplant < 6 months
- History of severe left ventricular outlet obstruction (either valvular or sub-valvular), severe mitral valve stenosis or severe aortic regurgitation
- Cardiac valvular abnormality that requires surgical correction
- Complex congenital heart disease
- Hypertrophic or restrictive cardiomyopathy
- significant pulmonary or hepatic disease that could interfere with the evaluation of safety or efficacy of TRV027
- life expectancy of less than 6 months
Trial locations and contacts
62 sites in 12 countries.
62 sites in 12 countries
Argentina11 sites
Research Site
Buenos Aires
Research Site
Córdoba
Research Site
Coronel Suárez
Research Site
Corrientes
Research Site
La Plata
Research Site
Morón
Research Site
Quilmes
Research Site
Rosario
Research Site
San Martin
Research Site
San Miguel de Tucumán
Research Site
Santa Fe
Poland9 sites
Research Site
Bad Nauheim
Research Site
Bialystok
Research Site
Grodzisk Mazowiecki
Research Site
Kłodzko
Research Site
Krakow
Research Site
Lublin
Research Site
Ruda Śląska
Research Site
Warsaw
Research Site
Wroclaw
Israel8 sites
Research Site
Afula
Research Site
Ashkelon
Research Site
Hadera
Research Site
Haifa
Research Site
Jerusalem
Research Site
Nahariya
Research Site
Nazareth
Research Site
Safed
Bulgaria7 sites
Research Site
Dimitrovgrad
Research Site
Kazanlak
Research Site
Pazardzhik
Research Site
Pleven
Research Site
Smolyan
Research Sites
Sofia
Research Site
Sofia
Romania5 sites
Research Site
Baia Mare
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Craiova
Research Site
Târgu Mureş
United States4 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Wayne State University
Detroit, Michigan, 48202
Michael E Debakey VA Medical Center
Houston, Texas, 77030
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388
Czechia4 sites
Research Site
Brno
Research Site
Hradec Králové
Research Site
Olomouc
Research Site
Prague
Germany3 sites
Research Site
Berlin
Research Site
Dortmund
Research Site
Greifswald
Russia3 sites
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Saratov
Slovakia3 sites
Research Site
Bratislava
Research Site
Kocise
Research Site
Martin
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
To evaluate the overall safety and efficacy of TRV027 when administered in addition to standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients hospitalized with Acute Decompensated Heart Failure (ADHF).
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- TRV027 Dose #1, TRV027 Dose #2, TRV027 Dose #3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRV027 Dose #1Drug
Also called Formerly known as TRV120027
TRV027 continuous intravenous infusion Dose #1
TRV027 Dose #2Drug
Also called Formerly known as TRV120027
TRV027 continuous intravenous infusion Dose #2
TRV027 Dose #3Drug
Also called Formerly known as TRV120027
TRV027 continuous intravenous infusion Dose #3
PlaceboDrug
Placebo continuous intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| TRV027 dose #1 | Experimental | TRV027 dose #1 via continuous IV infusion Receives: Drug: TRV027 Dose #1 |
| TRV027 dose #2 | Experimental | TRV027 dose #2 via continuous IV infusion Receives: Drug: TRV027 Dose #2 |
| TRV027 dose #3 | Experimental | TRV027 dose #3 via continuous IV infusion Receives: Drug: TRV027 Dose #3 |
| Placebo | Placebo comparator | Placebo via continuous IV infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite z score
The primary clinical endpoint is a of the following outcomes: (1) time from randomization to death through day 30, (2) time from randomization to heart failure re-hospitalization through day 30, (3) time from randomization to worsening heart failure through day 5, (4) change in dyspnea VAS score (calculated area under the curve) from baseline through day 5, and (5) length of initial hospital stay (in days) from randomization. The component outcomes will be combined by deriving an average Z for each patient.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionSep 2016
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevena Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Soergel, MD, Study director, Trevena Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966601
- Sponsor's protocol ID
- CP027.2002
- Acronym
- BLAST-AHF
- Status last verified
- Jul 2018
- First submitted
- 2 Sep 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT01966601
- Acronym / sponsor ID
- BLAST-AHF / CP027.2002
- Conditions
- Acute Decompensated Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Trevena Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Oct 2013 (estimated)
- 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.
To evaluate the overall safety and efficacy of TRV027 when administered in addition to standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients hospitalized with Acute Decompensated Heart Failure (ADHF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TRV027 dose #1 | Experimental | Drug: TRV027 Dose #1TRV027 dose #1 via continuous IV infusion |
| TRV027 dose #2 | Experimental | Drug: TRV027 Dose #2TRV027 dose #2 via continuous IV infusion |
| TRV027 dose #3 | Experimental | Drug: TRV027 Dose #3TRV027 dose #3 via continuous IV infusion |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo via continuous IV infusion |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men or women aged ≥21 years and ≤ 85 years 1a.Women of non-child-bearing potential
- Able to provide written informed consent
- Pre-existing diagnosis of heart failure and at least 30 days treatment with daily oral loop diuretics
- Systolic blood pressure ≥105 mmHg and ≤ 160 mmHg within 30 minutes of randomization
- Ventricular rate ≤125 bpm. Patients with rate-controlled persistent or permanent atrial fibrillation (aFib) at screening are permitted.
Key exclusion criteria (33 listed)
- Women who are pregnant or breast-feeding
- Clinical presentation:
- Medications:
- Medical history:
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 |
|---|---|---|
| TRV027 Dose #1Also: Formerly known as TRV120027TRV027 continuous intravenous infusion Dose #1 | Drug | TRV027 dose #1 |
| TRV027 Dose #2Also: Formerly known as TRV120027TRV027 continuous intravenous infusion Dose #2 | Drug | TRV027 dose #2 |
| TRV027 Dose #3Also: Formerly known as TRV120027TRV027 continuous intravenous infusion Dose #3 | Drug | TRV027 dose #3 |
| PlaceboPlacebo continuous intravenous infusion | Drug | Placebo |
Primary outcome
composite z score
Time frame: 30 days
The primary clinical endpoint is a of the following outcomes: (1) time from randomization to death through day 30, (2) time from randomization to heart failure re-hospitalization through day 30, (3) time from randomization to worsening heart failure through day 5, (4) change in dyspnea VAS score (calculated area under the curve) from baseline through day 5, and (5) length of initial hospital stay (in days) from randomization. The component outcomes will be combined by deriving an average Z for each patient.
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 Jul 2018.
Related trials for Acute Decompensated Heart Failure
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
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Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
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Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
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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.
David Soergel, MD study director
Trevena Inc.
62 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRV027 Dose #1, TRV027 Dose #2 and TRV027 Dose #3 in people with Acute Decompensated Heart Failure, run by Trevena Inc. at 62 sites in 12 countries.
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 16 inclusion and 33 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Argentina, Poland, Israel, Bulgaria, Romania and 7 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
composite z score (time frame: 30 days). 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 Jul 2018.