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CONSTATHE: Control of Sinus Node Tachycardia as an Additional Therapy in Patients With Decompensated Heart Failure

Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT02236247
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
50
Enrollment
1
Location
2
Arms
51
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Heart Rate Control as an Additional Therapeutic Strategy in Patients With Decompensated Heart Failure: a Prospective, Randomized, Double-blinded, Placebo-controlled Study.
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
Jan 1, 2017
Anticipated Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: ivabradine

I(f) inhibitor, heart rate controller

Drug: ivabradine
5 mg oral twice daily
Other Names:
  • procoralan

    		•
    Placebo Comparator: placebo

    placebo pill will be administered orally twice daily

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline heart rate [Baseline, day 5 after intervention]

      Heart rate will be assessed at morning, after 30 minutes of rest, recorded by electrocardiogram.

    Secondary Outcome Measures

    1. Change from baseline blood pressure [Baseline, day 5 after intervention]

      Blood pressure will be measured at morning by electronic cuff

    2. Change from baseline ejection fraction [Baseline, day 5 after intervention]

      Ejection fraction will be measured by echocardiography using Simpson´s rule

    3. Change from baseline stroke volume [Baseline, day 5 after intervention]

      Stroke volume will be measured by echocardiography using Doppler velocity-time integral technique.

    4. Change from baseline creatinine [Baseline, day 5 after intervention]

      Serum creatinine will be measured

    5. Change from baseline brain natriuretic peptide [Baseline, day 5 after intervention]

      Serum brain natriuretic peptide will be measured

    6. Clinical [Up to 6 months]

      Time of survival and free of readmission

    Other Outcome Measures

    1. Safety/Adverse Event Outcome Measure [Up to day 15 days after intervention]

      Number of Participants with Serious and Non-Serious Adverse Events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School Sao Paulo Brazil 05403-900

    Sponsors and Collaborators

    • University of Sao Paulo
    • Fundação de Amparo à Pesquisa do Estado de São Paulo

    Investigators

    • Study Chair: Edimar A Bocchi, MD-PHD, Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Marco Stephan Lofrano Alves, MD, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02236247
    Other Study ID Numbers:
    • CAAE:09145612.8.0000.0068
    • 2012/06163-6
    First Posted:
    Sep 10, 2014
    Last Update Posted:
    Jan 2, 2017
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Marco Stephan Lofrano Alves, MD, University of Sao Paulo
    ivabradine
    heart rate
    heart failure
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jan 2, 2017