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

NCT ID: NCT01733134

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

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.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standard therapy plus Tolvaptan

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

Group Type: EXPERIMENTAL

Tolvaptan

Intervention Type: DRUG

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

Standard therapy plus placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

Tolvaptan

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

Samsca

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

Sponsor Role: collaborator

Maisel, Alan, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan S Maisel, MD

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ACTIVATE117

Identifier Type: -

Identifier Source: org_study_id