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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02236247
Other study ID # CAAE:09145612.8.0000.0068
Secondary ID 2012/06163-6
Status Recruiting
Phase Phase 1/Phase 2
First received September 2, 2014
Last updated December 30, 2016
Start date May 2013
Est. completion date August 2017

Study information

Verified date December 2016
Source University of Sao Paulo
Contact Marco S. Alves, MD
Phone +55 11 981431512
Email marco.alves@incor.usp.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate control in patients with decompensated heart failure (DHF).


Description:

Sympathetic hyperactivity and consequent increase in heart rate (HR) are physiological responses to low cardiac output in patients with decompensated heart failure (DHF). However, elevated HR may become inappropriate in these patients, increasing myocardial oxygen demand and decreasing diastolic filling time and might lead to hemodynamic deterioration, ventricular dysfunction (tachycardiomyopathy) and clinical deterioration.

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Sinus node rhythm

- HR> 80 bpm

- Hospitalization for DHF

- Ejection fraction = 40%

- Sign informed consent

Exclusion Criteria:

- Systolic blood pressure <85 mmHg

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ivabradine
5 mg oral twice daily
Placebo
A placebo pill (identical to ivabradine) will be administered twice daily

Locations

Country Name City State
Brazil Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 Hear — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Safety/Adverse Event Outcome Measure Number of Participants with Serious and Non-Serious Adverse Events Up to day 15 days after intervention Yes
Primary Change from baseline heart rate Heart rate will be assessed at morning, after 30 minutes of rest, recorded by electrocardiogram. Baseline, day 5 after intervention Yes
Secondary Change from baseline blood pressure Blood pressure will be measured at morning by electronic cuff Baseline, day 5 after intervention Yes
Secondary Change from baseline ejection fraction Ejection fraction will be measured by echocardiography using SimpsonĀ“s rule Baseline, day 5 after intervention No
Secondary Change from baseline stroke volume Stroke volume will be measured by echocardiography using Doppler velocity-time integral technique. Baseline, day 5 after intervention Yes
Secondary Change from baseline creatinine Serum creatinine will be measured Baseline, day 5 after intervention Yes
Secondary Change from baseline brain natriuretic peptide Serum brain natriuretic peptide will be measured Baseline, day 5 after intervention No
Secondary Clinical Time of survival and free of readmission Up to 6 months No
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