Endothelial Function and Cardiac Output in RV Pacing

NCT00508196 | Completed Results DMC

• 1 other identifier: 190906ver3
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Pacing from the right ventricle (as is current practice in patients implanted with permanent pacemakers for bradycardia), has been associated with worse outcomes particularly in heart failure patients. Recent clinical trials suggest that chronic right ventricular pacing (VP) is associated with worsening heart failure, increased strokes and atrial fibrillation. Hemodynamically, right VP results in delayed activation and contraction of the LV which can give rise to functional mitral regurgitation, shortened diastolic filling time and thus reduced coronary filling, as well as abnormal arterial pulsatile flow. The mechanisms for the deleterious effects of right VP in heart failure patients have not been previously investigated. Our aim of this study is therefore to investigate the hemodynamic effects of right VP in stable heart failure patients in terms of exercise cardiac output (CO, an important measure of myocardial function and prognosis), as well as endothelial function which may be deranged as a result of abnormal arterial pulsatile flow.

Conditions

Bradycardia

Keywords

right ventricular pacing; endothelial function; cardiac output

Outcome Measures

Primary Outcomes (1)

• Endothelial Function Assessed by Flow Mediated Vasodilatation

  Flow mediated vasodilatation as measured by reactive hyperaemia peripheral arterial tonometry signal using EndoPAT software, Itamar. A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT software, providing the EndoPAT index (EnFI)

  1 week

Secondary Outcomes (2)

• B-type Natriuretic Pepetide

  1 week

• Cardiac Output

  1 week

Interventions

RVP-min OTHER

DDD pacing with long AV delay

Also known as: DDD Long

RVP-max OTHER

DDD pacing with short AV delay

Also known as: DDD short

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dual chamber pacemaker
• Intact AV node function

You may not qualify if:

• Unstable angina, heart failure
• Inability to exercise

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Ninewells Hospital and medical School

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: DR Anna Maria Choy
• Organization: University of Dundee

a.choy@dundee.ac.uk

01382 383482

Study Officials

• Allan Struthers, MD

  University of Dundee

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 27, 2007
• Study Start: November 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: March 18, 2019
• Results First Posted: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)