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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011133
Enrollment
115
Registered
2017-01-30
Start date
2010-04-07
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

I50

Interventions

Group 1: Examination of right heart function as a predictor for the cardiac resynchronization therapy in patients with left heart failure

Sponsors

Universitätsklinikum Magdeburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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) 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
positive clinical response to CRT measured in terms of quality of life

Countries

Germany

Contacts

Public ContactJan Smid

Universitätsklinikum Magdeburg, Klinik für Kardiologie

jan.smid@med.ovgu.de0391-6715190

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 7, 2026