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

January 17, 2013 updated by: Maisel, Alan, M.D.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Standard therapy plus Tolvaptan
Patient in the interventional group will receive tolvaptan in addition to standard therapy
Drug: 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.
Other Names:
  • Samsca
PLACEBO_COMPARATOR: Standard therapy plus placebo
Drug: placebo
Patient in the placebo group will receive tolvaptan in addition to standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 9 hours
Dyspnea will be evaluated at 9 hours
9 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: during hospitalizaton
The length of hospitalization will be compared between the placebo and interventional cohorts
during hospitalizaton
Rehospitalization
Time Frame: 30 days
The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisel, Alan, M.D.

Collaborators

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

Investigators

  • Principal Investigator: Alan S Maisel, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (ESTIMATE)

November 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIVATE117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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