The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device

Heart Failure. Clinical Trial

Official title:

The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698398
• Other study ID #: H-1-2012-092
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: February 10, 2014
• Start date: October 2012

Study information

• Verified date: October 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Commitee.
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients. The hypothesis is that it is possible to increase peak oxygen consumption by incrementally increasing CF-LVAD pumpspeed during exercise.

The study population will consist of severe heart failure patients with CF-LVADs treated at The Heart Centre of Copenhagen University Hospital Rigshospitalet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2013
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HeartMate II patients who underwent surgery and follow-up at The Heart Centre of Rigshospitalet.

• Heart failure in stable phase without the need for intravenous inotropic therapy.

• Ischemic and non-ischemic cardiomyopathy.

Exclusion Criteria:

• Severe aortic insufficiency.

Study Design

Allocation: Randomized, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure.

Intervention

Device:
• Incremental pump speed of CF-LVAD.
Peak oxygen consumption with fixed versus incremental pump speed.

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.	Copenhagen.

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exercise time (minutes), anerobic threshold.		Day 1
Primary	Peak oxygen consumption.	ml oxygen/minute/kg	Day 1
Secondary	Working capacity.	Watt	Day 1