Recruiting

Ivabradine with Dobutamine

Sponsor:

Loyola University

Code:

NCT03387605

Conditions

Heart Failure

Cardiogenic Shock

Tachycardia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ivabradine

Placebo

Study Details

Brief summary:

This is a randomized, double blind, single center trial to study of the effects of Ivabradine vs. Placebo on patients hospitalized for Stage D heart failure (HF)/ and cardiogenic shock (CS) who will require continuous infusion of Dobutamine and have developed sinus tachycardia (ST) (heart rate >100 beats/min).

The aim of the study will be to assess the potential of Ivabradine to slow ST and improve hemodynamics in patients with stage D HF/CS on Dobutamine treatment.

Conditions

Heart Failure

Cardiogenic Shock

Tachycardia

Study ID

NCT03387605

Start date

Mar 15, 2018

Status verified date

May, 2019

Completion date

Jun, 2020

Anticipated

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provide written informed consent for the study
  • Have current diagnosis of Ischemic and/or non-ischemic cardiomyopathy
  • Left ventricular ejection fraction (LVEF) < 30% by echo during the screening
  • Sinus rhythm with HR ≥100 bpm
  • Systolic blood pressure ≥ 90 mmHg assessed by cuff sphygmomanometer
  • CI < 2.2 L/min/m2
  • Current symptom(s) of HF (New York Heart Association (NYHA) class IV) at Screening.
  • Absence of hypovolemia, defined as a central venous pressure ≥10 mmHg and pulmonary capillary occlusion pressure ≥15 mmHg before administration of Dobutamine

Exclusion Criteria:

  • Respiratory support with mechanical ventilation
  • Circulatory mechanical support
  • Atrial pacing with the presence of sick sinus syndrome or sino-atrial block
  • Second or third degree atrioventricular (AV) block,
  • Atrial fibrillation/flutter
  • Amiodarone treatment
  • Ventricular tachycardia
  • Acute coronary syndrome
  • Bilirubin > 2.5
  • Alanine aminotransferase (ALT) >60 IE/L,
  • Serum creatinine >2.5 g/ml)
  • Fever and significant infection
  • Pregnancy
  • Anemia, Hgb < 9.0
  • Patients required treated with severe cytochrome CYP3A4 inhibitors drugs Concomitant use of strong CYP3A4 inhibitors will be avoided during the study period

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ivabradine

Initiation at dose 5 mg PO x 1 dose and further increased in 12 hours to 7.5 mg PO twice per day if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm

placebo comparator: Placebo

Matching placebo given PO twice per day

Interventions

Ivabradine

ivabradine or placebo given orally 2 times daily for 72 hours

Placebo

matching placebo given 2 times daily for 72 hours

Primary outcome measure

  • Heart rate [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Eugenia Raichlin, MD

708 327-2738Eugenia.Raichlin@lumc.edu

Max Liebo, MD

708 327-2738mliebo@lumc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

More Information

Sponsor

Loyola University

Last update posted

May 23, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2019-05-23.