The effect of implantation of biventricular pacemaker with or without defibrillator on blood vessels function and electrical changes in the hearts of patients with severe heart failure

The effect of implantation of biventricular pacemaker with or without defibrillator on endothelial functions and electrical and mechanical cardiac remodelling in patients with severe heart failure after 6months.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000895583

Acronym

InCARP

Enrollment

Registered

2015-08-27

Start date

2013-08-06

Completion date

2015-09-04

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The planned studies will evaluate the central-peripheral interactions in cardiac resynchronisation therapy to determine the changes induced by the process and their various roles in modulating overall clinical response in patients with heart failure

Interventions

Implantation of biventricular pacemaker with or without automatic implantable defibrillator according to conventional indications. The approximate duration of the implantation procedure is 2 to 3 hours

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Patients in whom CRT with or without Implantable Cardioverter Defibrillator (ICD) insertion is planned will be eligible for the study irrespective of the bases underlying heart failure

Exclusion criteria

a. Inability to attend for follow-up evaluation b. Treatment with inhibition of platelet ADP receptor activation e.g Clopidogrel c. Anticipated limitation of exercise capacity due to non cardiac disease eg Severe COPD d. Severe renal failure, Creatinine >3mg/dl (265.2micromol/L) or on dialysis. e. Expected life expantancy less than 1 year due to non cardiac causes f. Inability to give informed consent

Outcome results