NCT02236247

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

September 2, 2014

Last Update Submit

December 30, 2016

Conditions

Decompensated Heart Failure

Keywords

ivabradineheart rateheart failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Change from baseline blood pressure

    Baseline, day 5 after intervention

  • Change from baseline ejection fraction

    Baseline, day 5 after intervention

  • Change from baseline stroke volume

    Baseline, day 5 after intervention

  • Change from baseline creatinine

    Baseline, day 5 after intervention

  • Change from baseline brain natriuretic peptide

    Baseline, day 5 after intervention

  • +1 more secondary outcomes

Other Outcomes (1)

  • Safety/Adverse Event Outcome Measure

    Up to day 15 days after intervention

Study Arms (2)

ivabradine

EXPERIMENTAL

I(f) inhibitor, heart rate controller

Drug: ivabradine

placebo

PLACEBO COMPARATOR

placebo pill will be administered orally twice daily

Drug: Placebo

Interventions

ivabradineDRUG

5 mg oral twice daily

Also known as: procoralan
ivabradine
PlaceboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sinus node rhythm
  • HR\> 80 bpm
  • Hospitalization for DHF
  • Ejection fraction ≤ 40%
  • Sign informed consent

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Related 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 Heart Lung Transplant. 2016 Oct;35(10):1260-1264. doi: 10.1016/j.healun.2016.06.005. Epub 2016 Jun 7. No abstract available.

    PMID: 27469019RESULT

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Edimar A Bocchi, MD-PHD

    Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School

    STUDY CHAIR

Central Study Contacts

Marco S. Alves, MD

CONTACT

+55 11 981431512marco.alves@incor.usp.br

Edimar A. Bocchi, MD-PHD

CONTACT

+55 11 2661-5419edimar.bocchi@incor.usp.br

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 10, 2014

Study Start

May 1, 2013

Primary Completion

January 1, 2017

Study Completion

August 1, 2017

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)