Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01425164

Enrollment

220

Registered

2011-08-29

Start date

2011-01-31

Completion date

2012-06-30

Last updated

2012-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina, Coronary Heart Disease, Hemodialysis

Keywords

hemodialysis, coronary heart disease, angina, betablocker, carvedilol, ivabradine

Brief summary

In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. Aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.

Interventions

DRUGIvabradine

ivabradine tablets, 5 to 7.5 mg bis-in-die.

DRUGCarvedilol

carvedilol tablets, 12.5 to 25 mg bis-in-die.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

Inclusion criteria

* documented CAD evidenced by either coronary angiography (\>50% diameter stenosis of a major coronary artery) or a previously documented myocardial infarction * transient ischemia evidenced by abnormalities during an exercise ECG (standard Bruce protocol), myocardial perfusion scintigraphy, or stress regional wall motion study done within 6 months of study entry

Exclusion criteria

* unstable angina pectoris * myocardial infarction or coronary revascularization within 3 months of study entry * an ECG abnormality interfering with exercise ST-segment interpretation (eg, ST-segment depression \>0.5 mm, QRS duration \>0.1 second, R-wave amplitude \<8 mm,preexcitation,or atrial fibrillation) * inability to undergo exercise testing * uncontrolled hypertension * other serious condition (medical, psychiatric, cognitive, or social) * symptoms of sufficient severity (Canadian class II or higher) to require antianginal medications other than nitrates * heart failure * greater than first-degree atrio-ventricular block, asthma, or other contraindications to betablocker therapy

Design outcomes

Primary

Measure	Time frame	Description
event-free survival	18 months	primary outcome was event-free survival at 18 months. The following ischemia related events were considered: death, resuscitation from ventricular tachycardia/fibrillation, nonfatal myocardial infarction, hospitalization for unstable angina, aggravation of angina requiring known antianginal therapy, and need for revascularization.

Countries

Italy

Contacts

Primary ContactGennaro Cice, MD

gennarocice@hotmail.com+390815666642

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026