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

Primary Purpose

Acute Heart Failure

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Tolvaptan

placebo

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring acute heart failure, emergency department, copeptin, adh antagonists

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure
Dyspnea at rest or minimal exertion per the patient
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.
Elevated BNP level >200 pg/ml, or NTproBNP > 1000pg/mL
Able to administer study drug within 8 hours from triage time

Inpatient Hospitalized Inclusion Only:

Co-peptin level > 27 pmol/L

Exclusion Criteria:

Unable to provide informed consent
Unable to have 30 day telephone follow up
Not expected to survive past 6 months
On Renal replacement therapy or creatinine >3.5
History of allergy or intolerance to Tolvaptan
Suspected Pregnancy
Cardiogenic Shock
Participation in any interventional trial in prior 30 days.
Receiving or planned to receive IV Inotropic therapy
ACS now or in the past 30 days
Treatment with IV infusion vasoactive drugs in the hour prior to enrollment
Temperature > 100.5
Heart Failure due to atrial fibrillation with Rapid Ventricular Response
SBP < 90 mmHg

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Standard therapy plus Tolvaptan

Standard therapy plus placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Dyspnea

Dyspnea will be evaluated at 9 hours

Secondary Outcome Measures

Length of stay

The length of hospitalization will be compared between the placebo and interventional cohorts

Rehospitalization

The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts

Full Information

NCT ID

NCT01733134

First Posted

November 20, 2012

Last Updated

January 17, 2013

Sponsor

Maisel, Alan, M.D.

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01733134

Brief Title

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

Acronym

ACTIVATE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maisel, Alan, M.D.

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure

Keywords

acute heart failure, emergency department, copeptin, adh antagonists

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard therapy plus Tolvaptan

Arm Type

Experimental

Arm Description

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

Arm Title

Standard therapy plus placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tolvaptan

Other Intervention Name(s)

Samsca

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Dyspnea

Description

Dyspnea will be evaluated at 9 hours

Time Frame

9 hours

Secondary Outcome Measure Information:

Title

Length of stay

Description

The length of hospitalization will be compared between the placebo and interventional cohorts

Time Frame

during hospitalizaton

Title

Rehospitalization

Description

The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure Dyspnea at rest or minimal exertion per the patient 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. Elevated BNP level >200 pg/ml, or NTproBNP > 1000pg/mL Able to administer study drug within 8 hours from triage time Inpatient Hospitalized Inclusion Only: Co-peptin level > 27 pmol/L Exclusion Criteria: Unable to provide informed consent Unable to have 30 day telephone follow up Not expected to survive past 6 months On Renal replacement therapy or creatinine >3.5 History of allergy or intolerance to Tolvaptan Suspected Pregnancy Cardiogenic Shock Participation in any interventional trial in prior 30 days. Receiving or planned to receive IV Inotropic therapy ACS now or in the past 30 days Treatment with IV infusion vasoactive drugs in the hour prior to enrollment Temperature > 100.5 Heart Failure due to atrial fibrillation with Rapid Ventricular Response SBP < 90 mmHg

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth B Gaul, RN

Phone

440-625-0499

comprehensiveresearch@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan S Maisel, MD

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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