Cardiovascular DiseasesPhase 4NCT01346072
Pilot Study of Using Copeptin to Predict Response to Tolvaptan
A Phase 4 study testing tolvaptan in people with Cardiovascular Diseases and Heart Diseases, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- What is being tested?
- tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female patients with a history of chronic symptomatic heart failure, defined as dyspnea on exertion or edema, due to cardiac dysfunction, of at least one month's duration
- Left ventricular ejection fraction ≤ 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening
- Meet baseline copeptin criteria for entry
- Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)
Who cannot join
- Current New York Heart Association Functional Class IV heart failure
- Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration
- Presence of clinical contraindications to tolvaptan
- Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months
- Cardiovascular surgical procedure within the past 4 weeks
- CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
Show all 13Show fewer
- History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
- Chronic uncontrolled diabetes mellitus as determined by the investigator.
- Supine systolic arterial blood pressure < 90 mmHg at screening
- Serum creatinine > 3.5 mg/dL at screening
- Serum potassium > 5.5 mEq/L or < 3.5 mEq/L at screening
- Subjects currently treated with hemofiltration or dialysis
- Subjects judged by the investigator to be unable to maintain accurate intake and output during their hospitalization related to medical or other problems
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure
This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lower quartile copeptin levels at screening (10 each). The treatment phase of the study will be a prospective, single-arm, open label protocol. All patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.
For analysis of study endpoints, patients in the single intervention arm will be stratified by a prospectively determined cut-point of copeptin level into two groups (≥10 versus <10 pmol/L). The copeptin level used for the two group stratification will be the blinded copeptin value obtained at baseline from the hospital phase prior to administration of tolvaptan.
Read the detailed description
The study screening strategy will be designed to enroll an enriched patient population by identifying patients at the high or low end of the spectrum of copeptin levels for outpatients with stable heart failure. This will be accomplished by blinded review of copeptin levels obtained during screening.
The primary endpoints for analysis will be 24 hour urine output and the change in body weight over 24 hours during the inpatient stay.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- Being tested
- tolvaptan
- Keywords
- tolvaptan, copeptin, heart failure, vasopressin antagonist
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Heart Failure, 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
oral, 30 mg, single dose, one time administration
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan | Other | Single arm study Receives: Drug: tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Output
Total urine output for 24 hours following tolvaptan administration
Measured: 24 hours
Body Weight
Change in body weight from baseline to 24 hours after tolvaptan administration
Measured: Change over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka America Pharmaceutical
- Responsible party
- Principal investigator, Kirkwood Adams, University of North Carolina, Chapel Hill
- Investigators
- Kirkwood F Adams, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346072
- Sponsor's protocol ID
- TOLCOPEP11
- Status last verified
- Apr 2017
- First submitted
- 29 Apr 2011
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01346072
- Acronym / sponsor ID
- TOLCOPEP11
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure
- Keywords
- tolvaptan, copeptin, heart failure, vasopressin antagonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lower quartile copeptin levels at screening (10 each). The treatment phase of the study will be a prospective, single-arm, open label protocol. All patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.
For analysis of study endpoints, patients in the single intervention arm will be stratified by a prospectively determined cut-point of copeptin level into two groups (≥10 versus <10 pmol/L). The copeptin level used for the two group stratification will be the blinded copeptin value obtained at baseline from the hospital phase prior to administration of tolvaptan.
Detailed description
The study screening strategy will be designed to enroll an enriched patient population by identifying patients at the high or low end of the spectrum of copeptin levels for outpatients with stable heart failure. This will be accomplished by blinded review of copeptin levels obtained during screening.
The primary endpoints for analysis will be 24 hour urine output and the change in body weight over 24 hours during the inpatient stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolvaptan | Other | Drug: tolvaptanSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients with a history of chronic symptomatic heart failure, defined as dyspnea on exertion or edema, due to cardiac dysfunction, of at least one month's duration
- Left ventricular ejection fraction ≤ 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening
- Meet baseline copeptin criteria for entry
- Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)
Key exclusion criteria (13 listed)
- Current New York Heart Association Functional Class IV heart failure
- Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration
- Presence of clinical contraindications to tolvaptan
- Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months
- Cardiovascular surgical procedure within the past 4 weeks
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: Samscaoral, 30 mg, single dose, one time administration | Drug | Tolvaptan |
Primary outcome
Urine Output
Time frame: 24 hours
Total urine output for 24 hours following tolvaptan administration
Body Weight
Time frame: Change over 24 hours
Change in body weight from baseline to 24 hours after tolvaptan administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kirkwood F Adams, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tolvaptan in people with Cardiovascular Diseases and Heart Diseases, run by University of North Carolina, Chapel Hill at 1 site 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 4 inclusion and 13 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urine Output (time frame: 24 hours). The study lists 2 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 17 May 2017.