Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure (TACTICS-HF)
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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 |
- 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.
- 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 ]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: | March 2014 |
| Estimated Primary Completion Date: | January 2014 (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) 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) 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 + 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 + 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 |
Inclusion Criteria:
- ≥ 18 years of age
- Daily oral dose of furosemide between 40 and 240mg (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
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>3.0mg/dl or estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 by MDRD calculation at baseline, or currently undergoing renal replacement therapy
- 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| Contact: Michael Felker, MD | 919-668-8919 | michael.felker@dm.duke.edu |
| Contact: Vibhuti Shah | 919-668-8343 | vibhuti.shah@duke.edu |
| 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 | |
| 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: | February 19, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Institutional Review Board |
Additional relevant MeSH terms:
|
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 May 16, 2013