Pilot Study of Using Copeptin to Predict Response to Tolvaptan
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27514
- University of North Carolina at Chapel Hill
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Tolvaptan
Single arm study
|
oral, 30 mg, single dose, one time administration
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Urine Output
時間枠：24 hours
|
Total urine output for 24 hours following tolvaptan administration
|
24 hours
|
|
Body Weight
時間枠：Change over 24 hours
|
Change in body weight from baseline to 24 hours after tolvaptan administration
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Change over 24 hours
|
協力者と研究者
捜査官
- 主任研究者：Kirkwood F Adams, MD、University of North Carolina, Chapel Hill
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。