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

NCT01733134 | Withdrawn Phase 3 DMC

• 1 other identifier: ACTIVATE117
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Heart Failure

Keywords

acute heart failure; emergency department; copeptin; adh antagonists

Outcome Measures

Primary Outcomes (1)

• Dyspnea

  Dyspnea will be evaluated at 9 hours

  9 hours

Secondary Outcomes (2)

• Length of stay

  during hospitalizaton

• Rehospitalization

  30 days

Study Arms (2)

Standard therapy plus Tolvaptan

EXPERIMENTAL

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

Drug: Tolvaptan

Standard therapy plus placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Tolvaptan DRUG

Tolvaptan 30 mg. tablet for subjects enrolled prior to first 8 hours of coming to an emergency department. Repeated daily up to 5th day.

Also known as: Samsca

Standard therapy plus Tolvaptan

placebo DRUG

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

Standard therapy plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Co-peptin level \> 27 pmol/L

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisel, Alan, M.D.: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator
• Thermo Fisher Scientific, Inc: collaborator

MeSH Terms

Conditions

Emergencies; Diabetes Insipidus

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alan S Maisel, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Last Updated: November 20, 2024

Record last verified: 2016-09