Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy

Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)

Sponsors

Lead sponsor: Maisel, Alan, M.D.

Collaborator: Otsuka Pharmaceutical Development & Commercialization, Inc.
Thermo Fisher Scientific

Source Maisel, Alan, M.D.
Brief Summary

Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.

Overall Status Unknown status
Start Date January 2013
Completion Date December 2014
Primary Completion Date June 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Dyspnea 9 hours
Secondary Outcome
Measure Time Frame
Length of stay during hospitalizaton
Rehospitalization 30 days
Enrollment 350
Condition
Intervention

Intervention type: Drug

Intervention name: Tolvaptan

Description: Tolvaptan 30 mg. tablet for subjects enrolled prior to first 8 hours of coming to an emergency department. Repeated daily up to 5th day.

Arm group label: Standard therapy plus Tolvaptan

Other name: Samsca

Intervention type: Drug

Intervention name: placebo

Description: Patient in the placebo group will receive tolvaptan in addition to standard therapy

Arm group label: Standard therapy plus placebo

Eligibility

Criteria:

Inclusion Criteria:

1. Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure

2. Dyspnea at rest or minimal exertion per the patient

3. Evidence of extracellular volume expansion by at least one of the following: JVD, Rales, Ascites, Edema or positive Chest X-ray defined as cardiomegaly, pulmonary vascular congestion, Kerley B-lines, pulmonary edema and/or pleural effusion.

4. Elevated BNP level >200 pg/ml, or NTproBNP > 1000pg/mL

5. Able to administer study drug within 8 hours from triage time

Inpatient Hospitalized Inclusion Only:

Co-peptin level > 27 pmol/L

Exclusion Criteria:

1. Unable to provide informed consent

2. Unable to have 30 day telephone follow up

3. Not expected to survive past 6 months

4. On Renal replacement therapy or creatinine >3.5

5. History of allergy or intolerance to Tolvaptan

6. Suspected Pregnancy

7. Cardiogenic Shock

8. Participation in any interventional trial in prior 30 days.

9. Receiving or planned to receive IV Inotropic therapy

10. ACS now or in the past 30 days

11. Treatment with IV infusion vasoactive drugs in the hour prior to enrollment

12. Temperature > 100.5

13. Heart Failure due to atrial fibrillation with Rapid Ventricular Response

14. SBP < 90 mmHg

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role
Alan S Maisel, MD Principal Investigator
Overall Contact

Last name: Elizabeth B Gaul, RN

Phone: 440-625-0499

Email: [email protected]

Verification Date

January 2013

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Standard therapy plus Tolvaptan

Arm group type: Experimental

Description: Patient in the interventional group will receive tolvaptan in addition to standard therapy

Arm group label: Standard therapy plus placebo

Arm group type: Placebo Comparator

Acronym ACTIVATE
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov