Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure
TACTICS-HF
The Targeting Acute Congestion With Tolvaptan In Congestive Heart Failure Study
1 other identifier
interventional
257
1 country
18
Brief Summary
The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
Started Oct 2012
Typical duration for phase_3 heart-failure
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
April 27, 2017
CompletedApril 27, 2017
March 1, 2017
3.3 years
July 17, 2012
January 6, 2017
March 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours
The number of patients with at least moderate improvement (as reported by patient) in dyspnea Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.
8 and 24 hours
Secondary Outcomes (13)
Renal Function
0, 24, 48 and 72 hours
Weight Loss
0, 24, 48, and 72 hours
Fluid Loss
0, 24, 48, and 72 hours
Dyspnea Likert
48 and 72 hours
Hospital Stay
7 days
- +8 more secondary outcomes
Study Arms (2)
Tolvaptan
EXPERIMENTALFixed-dose IV furosemide (1 x total daily oral dose given intravenously in divided doses Q12 hours OR 40 mg IV Q12 hours, whichever is greater) + oral Tolvaptan (given at 0, 24 and 48 hours)
Placebo
PLACEBO COMPARATORFixed-dose IV furosemide (1 x total daily oral dose given intravenously in divided doses Q12 hours OR 40 mg IV Q12 hours, whichever is greater) + oral placebo (given at 0, 24 and 48 hours)
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Daily oral dose of furosemide between ≥ 40 mg(or equivalent)
- Identified within 24 hours of presentation, defined for purposes of this study as the time of initial dose of intravenous loop diuretic
- Prior clinical HF diagnosis that was treated with oral loop diuretics for at least 1 month
- Admission for acute decompensated Heart Failure (HF) as determined by
- dyspnea at rest or with minimal exertion
- Brain Natriuretic Peptide (BNP) \> 400 or NTproBNP \> 2000 pg/mL
- AND at least one of the following additional signs and symptoms:
- Orthopnea
- Peripheral edema
- Elevated JVP (Jugular Venous Pressure)
- Pulmonary rales
- Congestion on Chest X-ray
- No plan for revascularization, cardiac transplant, of ventricular assist device implantation, or other cardiac surgery within 60 days of randomization
- Signed informed consent
You may not qualify if:
- Serum Na \> 140 meq/L
- Received IV vasoactive treatment or ultra-filtration therapy for HF since initial presentation
- Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for HF
- Systolic Blood Pressure (SBP)\<90mmHg
- Serum-Cr\>3.5mg/dl or currently undergoing renal replacement therapy
- Known underlying liver disease
- Hemodynamically significant arrhythmias
- ACS(Acute coronary syndrome) within 4 weeks prior to study entry
- Active myocarditis
- Hypertrophic obstructive, restrictive, constrictive cardiomyopathy
- Severe stenotic valvular disease
- Complex congenital heart disease
- Constrictive pericarditis
- Clinical evidence of digoxin toxicity
- Need for mechanical hemodynamic support
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (18)
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, 80045, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Northeast Georgia Heart Center
Gainesville, Georgia, 30501, United States
Mercer University School of Medicine
Macon, Georgia, 31201, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Novant Health Heart and Vascular
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27713, United States
Southeastern Regional Medical Center
Lumberton, North Carolina, 28358, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065, United States
Grand View - Lehigh Valley Health Services
Sellersville, Pennsylvania, 18960, United States
UT Southwestern Medical center
Dallas, Texas, 75390, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042, United States
Related Publications (1)
Felker GM, Mentz RJ, Cole RT, Adams KF, Egnaczyk GF, Fiuzat M, Patel CB, Echols M, Khouri MG, Tauras JM, Gupta D, Monds P, Roberts R, O'Connor CM. Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure. J Am Coll Cardiol. 2017 Mar 21;69(11):1399-1406. doi: 10.1016/j.jacc.2016.09.004. Epub 2016 Sep 18.
PMID: 27654854DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- G. Michael Felker, MD
- Organization
- Duke Clinical Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Felker, MD
Duke Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2012
First Posted
July 19, 2012
Study Start
October 1, 2012
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 27, 2017
Results First Posted
April 27, 2017
Record last verified: 2017-03