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

Phase 3

Withdrawn

• Conditions: Acute Heart Failure
• Interventions: Drug: Tolvaptan; Drug: placebo

• Registration Number: NCT01733134
• Lead Sponsor: Maisel, Alan, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-26
• Status Verified: 2016-09
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapy plus Tolvaptan	Tolvaptan	Patient in the interventional group will receive tolvaptan in addition to standard therapy
Standard therapy plus placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Dyspnea	9 hours	Dyspnea will be evaluated at 9 hours

Secondary Outcome Measures

Name	Time	Method
Length of stay	during hospitalizaton	The length of hospitalization will be compared between the placebo and interventional cohorts
Rehospitalization	30 days	The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts