---
title: Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
nct_id: NCT02166060
overall_status: UNKNOWN
phase: PHASE4
sponsor: Medical University of Warsaw
study_type: INTERVENTIONAL
primary_condition: Heart Failure
countries: Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02166060.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02166060"
ct_last_update_post_date: 2014-06-18
last_seen_at: "2026-05-12T06:08:57.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy

**NCT ID:** [NCT02166060](https://clinicaltrials.gov/study/NCT02166060)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Medical University of Warsaw
- **Conditions:** Heart Failure
- **Start Date:** 2014-08
- **Completion Date:** 2016-10
- **CT.gov Last Update:** 2014-06-18

## Brief Summary

The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing.

The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing \<95% will and heart rate \<70 at rest and \>50% of heart rate in device memory \>70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.

## Detailed Description

Approximately 30% of CRT recipients do not respond to therapy. One of the causes ot that is unsatisfactory percentage of biventricular pacing. Patients may loose biventricular pacing because of inadequate sinus tachycardia.

Ivabradine may prevent inadequate sinus tachycardia and improve quality of live of CRT recipients.

According to current guidelines ivabradine is recommended in patients with symptomatic heart failure with heart rate at rest \>70.

The hypothesis of this study is that ivabradine may increase percentage of biventricular pacing in CRT recipients who have unsatisfactory percentage of biventricular pacing and \>50% of heart rate in device memory \>70.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* heart failure NYHA II-IV
* left ventricular ejection fraction =\<35%
* CRT-D implanted over 3 months ago
* optimal CRT-D parameters
* biventricular pacing \<95% despite the optimal parameters of the device
* optimal pharmacotherapy with the highest well-tolerated beta-adrenolytic dosage
* heart rate at rest below 70 bpm
* over 50% of heart rhythm over 70 bpm at interrogation with the device

Exclusion Criteria:

* persistent atrial fibrillation/flutter
* device associated ineffective resynchronization
* contraindications to ivabradine
```

## Arms

- **Ivabradine** (EXPERIMENTAL) — Ivabradine 5 mg twice a day or 7,5 mg twice a day

## Interventions

- **Ivabradine** (DRUG) — Ivabradine 5 mg twice a day or 7,5 mg twice a day

## Primary Outcomes

- **Percentage of biventricular pacing >95%** _(time frame: 6 months)_

## Secondary Outcomes

- **Percentage of biventricular pacing >98%** _(time frame: 6 months)_
- **Time to first inappropriate shock** _(time frame: 6 months)_
- **change of mean heart rate compared with baseline** _(time frame: 6 months)_
- **Cardiovascular hospitalization** _(time frame: 6 months)_
- **The change between baseline and final echocardiographic parameters** _(time frame: 6 months)_
- **The assessment of quality of life (SF36)** _(time frame: 6 months)_
- **The change between baseline and final NYHA class** _(time frame: 6 months)_

## Locations (1)

- 1st Department of Cariology of Medcial University of Warsaw, Warsaw, Masovian Voivodeship, Poland

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.1st department of cariology of medcial university of warsaw|warsaw|masovian voivodeship|poland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02166060.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02166060*  
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