Pilot Study of Using Copeptin to Predict Response to Tolvaptan
This study is ongoing, but not recruiting participants.
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Kirkwood Adams, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01346072
First received: April 29, 2011
Last updated: June 10, 2012
Last verified: June 2012
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Purpose
This 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases Heart Diseases Heart Failure |
Drug: tolvaptan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Urine output [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Total urine output for 24 hours following tolvaptan administration
Secondary Outcome Measures:
- Body weight [ Time Frame: Change over 24 hours ] [ Designated as safety issue: No ]Change in body weight from baseline to 24 hours after tolvaptan administration
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Tolvaptan
Single arm study
|
Drug: tolvaptan
oral, 30 mg, single dose, one time administration
Other Name: Samsca
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
- 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
j. Subjects judged by the investigator to be unable to maintain accurate intake and output during their hospitalization related to medical or other problems
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346072
Locations
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27514 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Otsuka America Pharmaceutical
Investigators
| Principal Investigator: | Kirkwood F Adams, MD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | Kirkwood Adams, Associate Professor of Medicine and Radiology, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01346072 History of Changes |
| Other Study ID Numbers: | TOLCOPEP11 |
| Study First Received: | April 29, 2011 |
| Last Updated: | June 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
tolvaptan copeptin heart failure vasopressin antagonist |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Heart Diseases Heart Failure |
ClinicalTrials.gov processed this record on May 22, 2013