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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Maisel, Alan, M.D.
Sponsor:
Collaborators:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Thermo Fisher Scientific
Information provided by (Responsible Party):
Maisel, Alan, M.D.
ClinicalTrials.gov Identifier:
NCT01733134
First received: November 20, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Acute Heart Failure
Drug: Tolvaptan
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy

Resource links provided by NLM:


Further study details as provided by Maisel, Alan, M.D.:

Primary Outcome Measures:
  • Dyspnea [ Time Frame: 9 hours ] [ Designated as safety issue: Yes ]
    Dyspnea will be evaluated at 9 hours


Secondary Outcome Measures:
  • Length of stay [ Time Frame: during hospitalizaton ] [ Designated as safety issue: Yes ]
    The length of hospitalization will be compared between the placebo and interventional cohorts

  • Rehospitalization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts


Estimated Enrollment: 350
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Samsca
Placebo Comparator: Standard therapy plus placebo Drug: placebo
Patient in the placebo group will receive tolvaptan in addition to standard therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733134

Contacts
Contact: Elizabeth B Gaul, RN 440-625-0499 comprehensiveresearch@gmail.com

Sponsors and Collaborators
Maisel, Alan, M.D.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Thermo Fisher Scientific
Investigators
Principal Investigator: Alan S Maisel, MD
  More Information

No publications provided

Responsible Party: Maisel, Alan, M.D.
ClinicalTrials.gov Identifier: NCT01733134     History of Changes
Other Study ID Numbers: ACTIVATE117
Study First Received: November 20, 2012
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Maisel, Alan, M.D.:
acute heart failure
emergency department
copeptin
adh antagonists

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014