Impact of right heart function and pulmonary venous Hypertension on CRT Response in patients with left ventricular dysfunction and dyssynchrony

Phase 4

• Conditions: I50; Heart failure

• Registration Number: DRKS00011133
• Lead Sponsor: niversitätsklinikum Magdeburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-12-07
• Study Start: 2017-01-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

1. Patients with heart failure symptoms lasting at least 6 weeks (according to the
current guidelines for CRT treatment of chronic heart failure)
2. At least 18 years of age
3. Medical need for implants (implants based on the standard implant guidelines
from the European Society of Cardiology (ESC))
4. Left ventricular ejection fraction (LVEF) < 35% as assessed by the investigator
5. NYHA functional status II, III or IV
6. QRS duration > 130 ms
7. Medical therapy, unless contraindicated, includes
- ACE inhibitor or
- AT1 blocker given for at least one month before enrolment,
- Beta-blocker started at least 3 months before enrolment,
- aldosterone antagonist
Dosage of therapies mentioned above must be unchanged for at least one month.
8. The patient must have given its written informed consent to participate in the
study after receiving adequate previous information and prior to any study
specific procedures.

Exclusion Criteria

1. Life expectancy < 12 months
2. Pregnancy (routine test before left and right heart catheter examination)
3. Prior CRT
4. Atrial arrhythmias
5. Right bundle branch block
6. QRS < 130 ms
7. Heart failure requiring continuous intravenous therapy
8. Patients with acute coronary syndromes or coronary revascularization within 4
months before CRT

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test whether parameters of right ventricular function, morphology and<br>pulmonary hemodynamic are able to predict the clinical outcome and the<br>remodeling of the right and left ventricle after CRT. <br>positive echocardiographic response (reduction of LVESV) to CRT within 6 month follow-up (primary);<br>positive clinical response to CRT measured by clinical response score<br>(co-primary),

Secondary Outcome Measures

Name	Time	Method
positive clinical response to CRT measured in terms of quality of life