on-responders of cardiac resynchronization therapy: the effect of left ventricular endocardial pacing and simulated exercise on acute hemodynamic response

Completed

Conditions: heart failure NYHA class III or IV
severe heart failure
10019280

Registration Number: NL-OMON32988

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

The Class I ACC/AHA/HRS 2008 recommendations for CRT in patients with severe systolic heart failure are used as inclusion criteria. This means that patients who have a LVEF less than or equal to 35%, a QRS duration greater than or equal to 0.12 seconds with sinus rhythm and NYHA functional class III or ambulatory class IV heart failure symptoms despite optimal recommended medical therapy will be included. Optimal recommended medical therapy is defined as the use of angiotensin-converting-enzyme inhibitors or angiotensin-II-receptor blockers and beta-blockers (unless they are not tolerated or contra-indicated). Although a Class IIa recommendation, patients with atrial fibrillation will also be included.

Exclusion Criteria

In case of following criteria patient will be excluded from our study: episode of acute heart failure within 3 months prior to inclusion, change in dosage of beta-blocker, angiotensin-converting enzyme inhibitor or angiotensin-II receptor blocker within 3 months prior to inclusion; unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery within 3 months prior to inclusion; chronic atrial arrhythmias other than atrial fibrillation; any mechanical or biological valve prosthesis, atrial septal defect, right-to-left shunt; severe pulmonary hypertension, uncontrolled arterial hypertension; known allergy to sulphur hexafluoride, end-stage renal or hepatic disease; pregnancy or child-bearing potential without the use of any birth control measurements; inability to provide a written informed consent; general contra-indications to magnetic resonance imaging.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>change in LV dP/dt max during left ventricular endocardial pacing OR during<br /><br>simulated exercise with dobutamine (depening on subgroup)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>change in NYHA functional class, quality of life determined by Minnesota Living<br /><br>With Heart Failure Questionnaire, 6-minutes walking test, change in left<br /><br>ventricular ejection fraction, change in left ventricular end-systolic and<br /><br>diastolic diameter and volume.</p><br>