Pilot Study of Using Copeptin to Predict Response to Tolvaptan

NCT01346072 | Completed Phase 4 Results

• 1 other identifier: TOLCOPEP11
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases; Heart Diseases; Heart Failure

Keywords

tolvaptan; copeptin; heart failure; vasopressin antagonist

Outcome Measures

Primary Outcomes (2)

• Urine Output

  Total urine output for 24 hours following tolvaptan administration

  24 hours

• Body Weight

  Change in body weight from baseline to 24 hours after tolvaptan administration

  Change over 24 hours

Study Arms (1)

Tolvaptan

OTHER

Single arm study

Drug: tolvaptan

Interventions

tolvaptan DRUG

oral, 30 mg, single dose, one time administration

Also known as: Samsca

Tolvaptan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Heart Failure; Diabetes Insipidus

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kirkwood F. Adams, Jr., MD
• Organization: University of North Carolina Chapel Hill

kfa@med.unc.edu

919-966-2877

Study Officials

• Kirkwood F Adams, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Radiology

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 17, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-04

Locations

US (1)