Pilot Study of Using Copeptin to Predict Response to Tolvaptan

Heart Failure Clinical Trial

Official title:

Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346072
• Other study ID #: TOLCOPEP11
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2011
• Last updated: May 19, 2015
• Start date: April 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Left ventricular ejection fraction = 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening

3. Meet baseline copeptin criteria for entry

4. Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)

Exclusion Criteria:

1. Current New York Heart Association Functional Class IV heart failure

2. Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration

3. Presence of clinical contraindications to tolvaptan

4. Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months

5. Cardiovascular surgical procedure within the past 4 weeks

6. CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.

7. History of primary significant liver disease or acute hepatic failure, as defined by the investigator.

8. Chronic uncontrolled diabetes mellitus as determined by the investigator.

9. Supine systolic arterial blood pressure < 90 mmHg at screening

10. Serum creatinine > 3.5 mg/dL at screening

11. Serum potassium > 5.5 mEq/L or < 3.5 mEq/L at screening

12. 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure

Intervention

Drug:
• tolvaptan
oral, 30 mg, single dose, one time administration

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine output	Total urine output for 24 hours following tolvaptan administration	24 hours	No
Secondary	Body weight	Change in body weight from baseline to 24 hours after tolvaptan administration	Change over 24 hours	No