Acute Heart FailurePhase 3ACTIVATENCT01733134
Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)
A Phase 3 study testing Tolvaptan in people with Acute Heart Failure, run by Maisel, Alan, M.D..
Trial summary
Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure
- Dyspnea at rest or minimal exertion per the patient
- Evidence of extracellular volume expansion by at least one of the following: JVD, Rales, Ascites, Edema or positive Chest X-ray defined as cardiomegaly, pulmonary vascular congestion, Kerley B-lines, pulmonary edema and/or pleural effusion.
- Elevated BNP level >200 pg/ml, or NTproBNP > 1000pg/mL
- Able to administer study drug within 8 hours from triage time
- Inpatient Hospitalized Inclusion Only:
- Co-peptin level > 27 pmol/L
Who cannot join
- Unable to provide informed consent
- Unable to have 30 day telephone follow up
- Not expected to survive past 6 months
- On Renal replacement therapy or creatinine >3.5
- History of allergy or intolerance to Tolvaptan
- Suspected Pregnancy
Show all 14Show fewer
- Cardiogenic Shock
- Participation in any interventional trial in prior 30 days.
- Receiving or planned to receive IV Inotropic therapy
- ACS now or in the past 30 days
- Treatment with IV infusion vasoactive drugs in the hour prior to enrollment
- Temperature > 100.5
- Heart Failure due to atrial fibrillation with Rapid Ventricular Response
- SBP < 90 mmHg
About this study
Official title: Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy
Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.
- Conditions
- Acute Heart Failure
- Being tested
- Tolvaptan, placebo
- Keywords
- acute heart failure, emergency department, copeptin, adh antagonists
- Medical subject headings
- Emergencies, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
Tolvaptan 30 mg. tablet for subjects enrolled prior to first 8 hours of coming to an emergency department. Repeated daily up to 5th day.
placeboDrug
Patient in the placebo group will receive tolvaptan in addition to standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy plus Tolvaptan | Experimental | Patient in the interventional group will receive tolvaptan in addition to standard therapy Receives: Drug: Tolvaptan |
| Standard therapy plus placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Dyspnea will be evaluated at 9 hours
Measured: 9 hours
Secondary outcomes (2)
Length of stay
The length of hospitalization will be compared between the placebo and interventional cohorts
Measured: during hospitalizaton
Rehospitalization
The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts
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 posted26 Nov 2012 (estimated)
Why it stopped: Sponsor decided to quit funding before any enrollments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisel, Alan, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc., Thermo Fisher Scientific, Inc
- Responsible party
- Sponsor
- Investigators
- Alan S Maisel, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733134
- Sponsor's protocol ID
- ACTIVATE117
- Acronym
- ACTIVATE
- Status last verified
- Sep 2016
- First submitted
- 20 Nov 2012
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy
- ClinicalTrials.gov ID
- NCT01733134
- Acronym / sponsor ID
- ACTIVATE / ACTIVATE117
- Conditions
- Acute Heart Failure
- Keywords
- acute heart failure, emergency department, copeptin, adh antagonists
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided to quit funding before any enrollments
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maisel, Alan, M.D.University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc., Thermo Fisher Scientific, Inc
- First posted
- 26 Nov 2012 (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.
Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy plus Tolvaptan | Experimental | Drug: TolvaptanPatient in the interventional group will receive tolvaptan in addition to standard therapy |
| Standard therapy plus placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure
- Dyspnea at rest or minimal exertion per the patient
- Evidence of extracellular volume expansion by at least one of the following: JVD, Rales, Ascites, Edema or positive Chest X-ray defined as cardiomegaly, pulmonary vascular congestion, Kerley B-lines, pulmonary edema and/or pleural effusion.
- Elevated BNP level >200 pg/ml, or NTproBNP > 1000pg/mL
- Able to administer study drug within 8 hours from triage time
Key exclusion criteria (14 listed)
- Unable to provide informed consent
- Unable to have 30 day telephone follow up
- Not expected to survive past 6 months
- On Renal replacement therapy or creatinine >3.5
- History of allergy or intolerance to Tolvaptan
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 |
|---|---|---|
| TolvaptanAlso: SamscaTolvaptan 30 mg. tablet for subjects enrolled prior to first 8 hours of coming to an emergency department. Repeated daily up to 5th day. | Drug | Standard therapy plus Tolvaptan |
| placeboPatient in the placebo group will receive tolvaptan in addition to standard therapy | Drug | Standard therapy plus placebo |
Primary outcome
Dyspnea
Time frame: 9 hours
Dyspnea will be evaluated at 9 hours
2 secondary outcomes
Length of stay
Time frame: during hospitalizaton
Rehospitalization
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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.
Alan S Maisel, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolvaptan in people with Acute Heart Failure, run by Maisel, Alan, M.D..
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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Dyspnea (time frame: 9 hours). 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 20 Nov 2024.