![11/15/13 Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure - Full Text View - ClinicalTrials.gov
clinicaltrials.gov/show/NCT01644331 1/4
This study is currently recruiting participants.
Verified September 2013 by Duke University
Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01644331
First received: July 17, 2012
Last updated: September 30, 2013
Last verified: September 2013
History of Changes
Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record
A service of the U.S. National Institutes of Health
Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure (TACTICS-HF)
Purpose
The purpose of this study is to see if taking tolvaptan by mouth in addition to the regular treatment received for shortness of breath due to heart
failure will work better than the regular treatment alone. The study will also look to see if other symptoms of heart failure or problems associated
with heart failure treatments, like changes in kidney function, are affected by tolvaptan.
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.
Condition Intervention Phase
Heart Failure
Dyspnea
Drug: Tolvaptan
Drug: Placebo
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Targeting Acute Congestion With Tolvaptan In Congestive Heart Failure Study
Resource links provided by NLM:
MedlinePlus related topics: Breathing Problems Heart Failure
Drug Information available for: Tolvaptan
U.S. FDA Resources
Further study details as provided by Duke University:
Primary Outcome Measures:
Dyspnea improvement measured by Likert scale at 8 and 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
The proportion of patients with at least moderate improvement in dyspnea by 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.
Secondary Outcome Measures:
Renal function [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Change from baseline blood urea nitrogen (BUN) at Day 7 or discharge Change from baseline serum creatinine at Day 7 or discharge
Body weight [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Change from baseline body weight at Day 7 or discharge
Fluid Loss [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]](https://image.slidesharecdn.com/targeting-acute-congestion-with-tolvaptan-in-congestive-heart-failure-full-text-view-clinicaltrials-160210064405/85/targeting-acute-congestion-with-tolvaptan-in-congestive-heart-failure-full-text-view-clinical-trials-1-320.jpg)
![11/15/13 Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure - Full Text View - ClinicalTrials.gov
clinicaltrials.gov/show/NCT01644331 2/4
Change from baseline fluid balance at Day 7 or discharge Change from baseline serum sodium at Day 7 or discharge
Breathing [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Change from baseline dyspnea at 72 hours
Hospital stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Total days spent in hospital from baseline until discharge or death
worsening heart failure [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Change from baseline heart failure assessment at Day 7 or discharge
Estimated Enrollment: 250
Study Start Date: October 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolvaptan
IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV
Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48
hours)
Drug: Tolvaptan
Tolvaptan (given at 0, 12, 24 and 48 hours)
Other Name: Samsca
Placebo Comparator: Placebo
IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours,
whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Drug: Placebo
IV furosemide (1 x oral dose given IV in Q12 hours
divided doses) plus oral placebo (given at 0, 12, 24 and
48 hours)
Other Name: Placebo
Detailed Description:
This study will be a randomized, double blind, placebo controlled, multi-center clinical trial of patients with signs and symptoms consistent with
acute heart failure (AHF) within 24 hours of presentation at Emergency Department. A total of approximately 250 patients will be enrolled in the
trial.
Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens:
Fixed-dose IV furosemide (1 x total daily oral dose) given intravenously in divided doses every 12 hours or 40 mg IV Q12 hours, whichever is
greater + oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Fixed-dose IV furosemide (1 x total daily oral dose) given intravenously in divided doses every 12 hours or 40 mg IV Q12 hours, whichever is
greater + oral placebo (given at 0, 12, 24 and 48 hours)
The study treatment regimen will be administered from randomization through 48 hours, at which point Tolvaptan/placebo will be discontinued and
all diuretic treatment will be adjusted at the treating physician's discretion.
The primary endpoint will be the proportion of patients with at least moderate improvement in dyspnea by 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.
Patients will be followed daily for the duration of hospitalization or for 7 days (whichever is shortest).
All patients will have Day 30 follow up phone contact for assessment of vital status and interval hospitalizations.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
≥ 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](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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Targeting acute congestion with tolvaptan in congestive heart failure full text view clinical trials
- 1. 11/15/13 Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure - Full Text View - ClinicalTrials.gov clinicaltrials.gov/show/NCT01644331 1/4 This study is currently recruiting participants. Verified September 2013 by Duke University Sponsor: Duke University Information provided by (Responsible Party): Duke University ClinicalTrials.gov Identifier: NCT01644331 First received: July 17, 2012 Last updated: September 30, 2013 Last verified: September 2013 History of Changes Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record A service of the U.S. National Institutes of Health Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure (TACTICS-HF) Purpose The purpose of this study is to see if taking tolvaptan by mouth in addition to the regular treatment received for shortness of breath due to heart failure will work better than the regular treatment alone. The study will also look to see if other symptoms of heart failure or problems associated with heart failure treatments, like changes in kidney function, are affected by tolvaptan. 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. Condition Intervention Phase Heart Failure Dyspnea Drug: Tolvaptan Drug: Placebo Phase 3 Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment Official Title: The Targeting Acute Congestion With Tolvaptan In Congestive Heart Failure Study Resource links provided by NLM: MedlinePlus related topics: Breathing Problems Heart Failure Drug Information available for: Tolvaptan U.S. FDA Resources Further study details as provided by Duke University: Primary Outcome Measures: Dyspnea improvement measured by Likert scale at 8 and 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ] The proportion of patients with at least moderate improvement in dyspnea by 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. Secondary Outcome Measures: Renal function [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] Change from baseline blood urea nitrogen (BUN) at Day 7 or discharge Change from baseline serum creatinine at Day 7 or discharge Body weight [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] Change from baseline body weight at Day 7 or discharge Fluid Loss [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- 2. 11/15/13 Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure - Full Text View - ClinicalTrials.gov clinicaltrials.gov/show/NCT01644331 2/4 Change from baseline fluid balance at Day 7 or discharge Change from baseline serum sodium at Day 7 or discharge Breathing [ Time Frame: 3 days ] [ Designated as safety issue: Yes ] Change from baseline dyspnea at 72 hours Hospital stay [ Time Frame: 7 days ] [ Designated as safety issue: No ] Total days spent in hospital from baseline until discharge or death worsening heart failure [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] Change from baseline heart failure assessment at Day 7 or discharge Estimated Enrollment: 250 Study Start Date: October 2012 Estimated Study Completion Date: August 2015 Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: Tolvaptan IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours) Drug: Tolvaptan Tolvaptan (given at 0, 12, 24 and 48 hours) Other Name: Samsca Placebo Comparator: Placebo IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours) Drug: Placebo IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours) Other Name: Placebo Detailed Description: This study will be a randomized, double blind, placebo controlled, multi-center clinical trial of patients with signs and symptoms consistent with acute heart failure (AHF) within 24 hours of presentation at Emergency Department. A total of approximately 250 patients will be enrolled in the trial. Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens: Fixed-dose IV furosemide (1 x total daily oral dose) given intravenously in divided doses every 12 hours or 40 mg IV Q12 hours, whichever is greater + oral Tolvaptan (given at 0, 12, 24 and 48 hours) Fixed-dose IV furosemide (1 x total daily oral dose) given intravenously in divided doses every 12 hours or 40 mg IV Q12 hours, whichever is greater + oral placebo (given at 0, 12, 24 and 48 hours) The study treatment regimen will be administered from randomization through 48 hours, at which point Tolvaptan/placebo will be discontinued and all diuretic treatment will be adjusted at the treating physician's discretion. The primary endpoint will be the proportion of patients with at least moderate improvement in dyspnea by 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. Patients will be followed daily for the duration of hospitalization or for 7 days (whichever is shortest). All patients will have Day 30 follow up phone contact for assessment of vital status and interval hospitalizations. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria: ≥ 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
- 3. 11/15/13 Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure - Full Text View - ClinicalTrials.gov clinicaltrials.gov/show/NCT01644331 3/4 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 Exclusion Criteria: 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 Terminal illness (other than heart failure) with expected survival time of less than 1 year History of adverse reaction to Tolvaptan Enrollment or planned enrollment in another randomized clinical trial during this hospitalization Pregnant or breast-feeding Inability to comply with planned study procedures Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01644331 Contacts Contact: Michael Felker, MD 919-668-8919 michael.felker@dm.duke.edu Contact: Vibhuti Shah 919-668-8343 vibhuti.shah@duke.edu Locations United States, North Carolina Duke University Medical Center Recruiting Durham, North Carolina, United States, 27713 Contact: Michael Felker, MD 919-668-8919 michael.felker@dm.duke.edu Sponsors and Collaborators Duke University Investigators Principal Investigator: Michael Felker, MD Duke Clinical Research Institute More Information No publications provided Responsible Party: Duke University ClinicalTrials.gov Identifier: NCT01644331 History of Changes Other Study ID Numbers: Pro00037557 Study First Received: July 17, 2012 Last Updated: September 30, 2013 Health Authority: United States: Data and Safety Monitoring Board United States: Institutional Review Board Additional relevant MeSH terms:
- 4. 11/15/13 Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure - Full Text View - ClinicalTrials.gov clinicaltrials.gov/show/NCT01644331 4/4 Dyspnea Heart Failure Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Heart Diseases Cardiovascular Diseases ClinicalTrials.gov processed this record on November 14, 2013