Overview

The Role of Chronotropic Incompetence in Heart Failure With Normal Ejection Fraction (HFNEF)

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
Summary
What is heart failure with normal ejection fraction? The heart contracts (pumps) and relaxes with each heartbeat. In some people with heart failure, the heart contracts normally but there is reduced relaxation of the heart. As a result, people notice a feeling of breathlessness, ankle swelling and fatigue especially on exertion. The investigators feel that patients with reduced or impaired relaxation of the heart have less heart filling time and poor energy utilisation during exercise. Therefore, the investigators are conducting a study to more thoroughly understand the disease condition by giving a drug called ivabradine to reduce the heart rate and hence to increase the heart filling time in these patients.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Oxford
Collaborator:
University of Aberdeen
Criteria
Inclusion Criteria:

- Participant who is willing and able to give informed consent for participation in the
study.

- Male or Female, aged 60 years and over (Group 1, Oxford).

- Patients diagnosed with HFNEF by ESC criteria and have peak V02 ≤ 85% with a cardiac
pattern of exercise limitation during CPEX (Group 1, Oxford).

- Hypertensive controls aged 65 and over without HFNEF and with peak V02 > 90% (Group 2,
Aberdeen)

- Able to perform exercise testing.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

- LVEF <50%

- Inability to tolerate MRI scanning (claustrophobia, inability to lie flat)

- Contraindications to CMR imaging (implantable devices or other metal implants,
internal cardioverter-defibrillator, cranial aneurysm clips, metallic ocular foreign
bodies, hypersensitivity to gadolinium)

- Presence of other significant concomitant diseases such as ischaemic, valvular,
pericardial heart disease or cardiomyopathy.

- Presence of asthma (contraindication to adenosine)

- Presence of 2nd or 3rd degree AV block (contraindications to ivabradine and adenosine)

- Presence of sick sinus syndrome

- Presence of atrial fibrillation

- Significant bradycardia (HR <60 per minute).

- Objective evidence of lung disease on formal lung function testing

- Female participant who is pregnant, lactating or planning pregnancy during the course
of the study

- Unable to perform exercise testing

- Patient who is in terminally ill or is inappropriate for medication

- Known hypersensitivity to Ivabradine or adenosine

- Significantly impaired renal function (eGFR<30ml/min)