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A randomised study on use of impedance cardiography for optimisation of cardiac resynchronisation therapy

A randomised study on use of impedance cardiography for optimisation of cardiac resynchronisation therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12205645
Enrollment
80
Registered
2006-09-27
Start date
2006-09-30
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Heart failure Circulatory System Heart failure

Interventions

A total of 80 patients will be recruited to the study: 1. Arm A: impedence cardiography - 40 patients will be assessed using Impedence Cardiography (ICG) to optimise treatment. 2. Arm B: standard card

Sponsors

Good Hope Hospital NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 80 patients who are referred to the cardiology clinic and meet the National Institute for Clinical Excellence (NICE) criteria for biventricular pacemaker implantation will be included in this study. The following inclusion criteria are: 1. Heart Failure 2. Moderate to severe function limitation New York Heart Association (NYHA) class III or IV, or NYHA class II heart failure plus a history of repeated admissions 3. Optimal tolerated treatment with diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, spironolactone and digoxin 4. QRS duration (representing the duration of ventricular depolarisation) more than or equal to 120 ms or evidence of mechanical Left Ventricular (LV) dyssynchrony 5. Left ventricular ejection fraction more than or equal to 40%

Exclusion criteria

Exclusion criteria: 1. Contraindications to cardiac pacing 2. Presence of comorbidities likely to threaten survival within 12 months 3. Pulmonary oedema requiring intravenous diuretics in the previous week

Design outcomes

Primary

MeasureTime frame
The primary objective is to assess whether the clinical benefits of cardiac resynchronisation therapy can be optimised using ICG both at the time of pacemaker implantation and during follow up. The primary endpoint is improvement in six minute walking distance.

Secondary

MeasureTime frame
Quality of Life using the Minnesota Living with Heart Failure questionnaire.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026