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

Acute Heart Failure Clinical Trial

— ACTIVATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01733134
• Other study ID #: ACTIVATE117
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 20, 2012
• Last updated: January 17, 2013
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: Maisel, Alan, M.D.
• Contact: Elizabeth B Gaul, RN
• Phone: 440-625-0499
• Email: comprehensiveresearch[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maisel, Alan, M.D.	Otsuka Pharmaceutical Development & Commercialization, Inc., Thermo Fisher Scientific

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea	Dyspnea will be evaluated at 9 hours	9 hours	Yes
Secondary	Length of stay	The length of hospitalization will be compared between the placebo and interventional cohorts	during hospitalizaton	Yes
Secondary	Rehospitalization	The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts	30 days	Yes