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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27514
- University of North Carolina at Chapel Hill
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Tolvaptan
Single arm study
|
oral, 30 mg, single dose, one time administration
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Urine Output
Tidsramme: 24 hours
|
Total urine output for 24 hours following tolvaptan administration
|
24 hours
|
|
Body Weight
Tidsramme: Change over 24 hours
|
Change in body weight from baseline to 24 hours after tolvaptan administration
|
Change over 24 hours
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kirkwood F Adams, MD, University of North Carolina, Chapel Hill
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nyresykdommer
- Urologiske sykdommer
- Sykdommer i det endokrine systemet
- Hypofyse sykdommer
- Hjertefeil
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Diabetes Insipidus
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Natriuretiske midler
- Antidiuretiske hormonreseptorantagonister
- Tolvaptan
Andre studie-ID-numre
- TOLCOPEP11
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