Control of Sinus Node Tachycardia as an Additional Therapy in Patients With Decompensated Heart Failure
NCT ID: NCT02236247
Last Updated: 2017-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2013-05-31
2017-08-31
Brief Summary
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Detailed Description
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Studies show the elevated HR is a predictor of poor prognosis in DHF. Subanalyses of large clinical trials using beta blockers (BBs) demonstrate the adequate control of HR correlates with a better outcome in patients with stable chronic heart failure (HF). However, use of BBs in patients with DHF is limited due to negative inotropic and hypotensive effects of these drugs.
As alternative to BBs, ivabradine has shown to increase survival of patients with chronic stable systolic HF. Compared to BBs, ivabradine has the advantage of "pure" negative chronotropic effect, no effect on myocardial contractility or peripheral vascular resistance. Despite the inhibition of I (f) has been validated as a therapeutic option in patients with stable HF, there are no studies available on this strategy in patients with DHF.
We hypothesized that HR control by ivabradine might improve clinical, hemodynamic and neurohormonal parameters in patients with DHF. The aim of this study was to evaluate the efficacy of HR control with ivabradine in patients with DHF.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ivabradine
I(f) inhibitor, heart rate controller
ivabradine
5 mg oral twice daily
placebo
placebo pill will be administered orally twice daily
Placebo
A placebo pill (identical to ivabradine) will be administered twice daily
Interventions
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ivabradine
5 mg oral twice daily
Placebo
A placebo pill (identical to ivabradine) will be administered twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HR\> 80 bpm
* Hospitalization for DHF
* Ejection fraction ≤ 40%
* Sign informed consent
Exclusion Criteria
* Signs of hypoperfusion
* Dobutamine\>15 mcg/Kg/min
* Acute myocarditis
* Primary valvular disease requiring surgery
* Stroke in the last three months
* Hypertrophic or restrictive cardiomyopathy
* Sinus node disease
* Atrial fibrillation or flutter
* Second or third degree atrio-ventricular blockade
* Long QT syndrome
* Severe pulmonary disease
* Pulmonary embolism in the last three months
* Need for invasive ventilatory support
* Septicemia or septic shock
* Hepatic failure
* Creatinine \> 2.5 mg/dL
* Hemodialysis
* Advanced malignancy
* Pregnancy or lactation
* Immunosuppressive therapy
* Use of cytochrome P450 inhibitors
18 Years
75 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
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Marco Stephan Lofrano Alves
MD
Principal Investigators
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Edimar A Bocchi, MD-PHD
Role: STUDY_CHAIR
Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School
Locations
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Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Lofrano-Alves MS, Issa VS, Biselli B, Chizzola P, Ayub-Ferreira SM, Bocchi EA. Control of sinus tachycardia as an additional therapy in patients with decompensated heart failure (CONSTATHE-DHF): A randomized, double-blind, placebo-controlled trial. J Heart Lung Transplant. 2016 Oct;35(10):1260-1264. doi: 10.1016/j.healun.2016.06.005. Epub 2016 Jun 7. No abstract available.
Other Identifiers
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2012/06163-6
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CAAE:09145612.8.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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