Status:
RECRUITING
Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes
Lead Sponsor:
IHF GmbH - Institut für Herzinfarktforschung
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized, parallel group controlled study examines the effect of supporting the Heart failure supply through pulmonary arterial (PA) pressure measurement with the CardioMEMS™ HF system to hard endpo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written consent received from the patient or a legal representative after the in-formation has been provided.
- ≥≥ 18 years of age.
- Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study.
- Objectified HF diagnosis for more than three months.
- Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms.
- Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
- Patients with reduced left ventricular ejection fraction (LVEF) ≤40% (diagnosed within 6 months prior to inclusion) must be treated with guideline-compliant HF pharmacotherapy; if one class of guideline-compliant medication is not tolerated, appropriate documentation must be supplied; patients must receive and tolerate at least one class of guideline-compliant medication; if no guideline-compliant medication is tolerated at all, the patient may not participate in the study.
- In patients with preserved LVEF (\>40%; diagnosed within 6 months prior to inclu-sion) comorbidities must be treated in accordance with guideline-compliant medi-cation.
- Chest circumference (measured at axillary level) of less than 165 cm if BMI \>35 kg/m2.
- Willing and mentally and physically able to meet the requirements for follow-up and long-term basic care (this includes the long-term willingness of the patient, and of their relatives where relevant, to participate in PA pressure-based monitor-ing).
- Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network) .
- For the intervention group: Implantation is only performed if the diameter of the pulmonary artery branch intended for implantation is ≥7 mm (assessment will be made during the right heart catheterization)
- Exclusion criteria:
- Enrolment in another study with an active treatment arm.
- Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission
- Therapy-refractory heart failure in ACC/AHA stage D or new therapies that have taken place or are planned in the next 12 months (e.g. implantation of a left ven-tricular assist system / transplantation)
- Active infection.
- History of recurrent (\>1 episode) pulmonary embolism and/or deep vein throm-bosis.
- Continuous or intermittent chronic inotropic therapy.
- Estimated glomerular filtration rate (eGFR) \<25 ml/min
- Life expectancy (according to the study physician's assessment) \<12 months.
- Severe, unrepaired congenital heart defect that would prevent implantation of the sensor.
- Severe valve vitium with planned intervention in the next 3 months
- Presence of a mechanical right heart valve.
- Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent.
- Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program.
- Women of childbearing age with a positive pregnancy test at the time of inclusion
Exclusion
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT04398654
Start Date
October 2 2020
End Date
December 31 2026
Last Update
October 18 2024
Active Locations (33)
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1
SLK-Kliniken GmbH - Klinikum am Plattenwald
Bad Friedrichshall, Germany
2
Kerckhoff-Klinik Forschungs GmbH
Bad Nauheim, Germany
3
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
4
BG Unfallkrankenhaus Berlin
Berlin, Germany