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Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02086422
Enrollment
Unknown
Registered
2014-03-13
Start date
2013-07-31
Completion date
Unknown
Last updated
2016-02-26

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

Conditions

Chronic Heart Failure

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.

Interventions

DRUGivabradine
DRUGPlacebo
OTHERExercise

Sponsors

The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Examining the effects of iatrogenic CI on exercise capacity24 monthsEach subject will undergo a full echocardiographic examination.We will assess LV systolic and diastolic function variables, mitral regurgitation, and pulmonary artery pressure.

Countries

United Kingdom

Contacts

Primary ContactKlaus Witte, FRCP, MD
k.k.witte@leeds.ac.uk01133926642

Outcome results

None listed

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