Iatrogenic Chronotropic Incompetence and Exercise Toleran... | NCT02086422

Studies
Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure

NCT02086422

Sponsor

The Leeds Teaching Hospitals NHS Trust

Status

Unknown status

Last Update Posted

Feb 26, 2016Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Chronic Heart Failure

Interventions

ivabradine
Placebo
Exercise

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Not provided

First Submitted Date

Nov 26, 2013

First Submission Date that Met QC Criteria

Mar 12, 2014

First Posted Date

Mar 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2016

Last Update Posted Date

Feb 26, 2016Estimated

Description Module

Brief Summary

Patients with CHF benefit from heart rate lowering, and the investigators have previously demonstrated that this does not adversely affect exercise tolerance. In a pacemaker population we also have shown that preventing heart rate lowering is detrimental in terms of symptoms and prognosis.

The aim of the study is to therefore to establish whether heart rate limitation in patients with heart failure has a negative impact on exercise capacity. If the investigators establish that this is not the case, physicians will be able to confidently prescribe heart rate lowering agents, and programme pacemakers to allow bradycardia without the concern that there will be detrimental effects of symptom.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ivabradine	Active Comparator	Exercise with ivabradine	Drug: ivabradine Other: Exercise
Placebo	Placebo Comparator	Exercise with placebo	Drug: Placebo Other: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ivabradine	Drug		ivabradine
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Examining the effects of iatrogenic CI on exercise capacity	Each subject will undergo a full echocardiographic examination.We will assess LV systolic and diastolic function variables, mitral regurgitation, and pulmonary artery pressure.	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to walk on a treadmill Able to provide consent Heart failure (or not) depending upon the arm. Patients with atrial fibrillation to have had an AV node ablation (or very slow response to AF)

Exclusion Criteria:

Cognitive impairment, known reaction to ivabradine, musculoskeletal issues limiting walking on a treadmill.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Klaus Witte, FRCP, MD	Contact	01133926642		k.k.witte@leeds.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leeds Teaching Hospitals NHS Trust	Recruiting	Leeds		LS2 9JT	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D000077550	Ivabradine
D015444	Exercise

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

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