Monitoring pulmonary artery pressure to improve heart failure outcomes

Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes

This study is testing if a new device that measures pressure in the lungs can help people with heart failure feel better and avoid hospital visits.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 554 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IHF GmbH - Institut für Herzinfarktforschung (Academic / other)
• Locations: 33 sites (Bad Friedrichshall and 32 other locations)
• Trial ID: NCT04398654 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the CardioMEMS™ HF system, which measures pulmonary artery pressure, in improving outcomes for patients with heart failure. It involves a randomized, parallel group controlled design where participants receive standard care alongside the implantation of the pressure sensor. The study focuses on patients predominantly in NYHA Stage III who have experienced recent hospitalizations due to heart failure. The intervention aims to optimize therapy based on real-time pressure monitoring data, with follow-up assessments to determine its impact on health outcomes and quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with heart failure symptoms classified as NYHA Stage III and recent hospital admissions due to heart failure.

Not a fit: Patients who do not have a diagnosis of heart failure or those who cannot tolerate guideline-compliant heart failure medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved management of heart failure and better patient outcomes.

How similar studies have performed: Other studies utilizing pulmonary artery pressure monitoring have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Written consent received from the patient or a legal representative after the in-formation has been provided.
2. ≥≥ 18 years of age.
3. Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study.
4. Objectified HF diagnosis for more than three months.
5. Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms.
6. Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
7. 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.
8. 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.
9. Chest circumference (measured at axillary level) of less than 165 cm if BMI \>35 kg/m2.
10. 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).
11. Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network) .
12. 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:

1. Enrolment in another study with an active treatment arm.
2. Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission
3. 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)
4. Active infection.
5. History of recurrent (\>1 episode) pulmonary embolism and/or deep vein throm-bosis.
6. Continuous or intermittent chronic inotropic therapy.
7. Estimated glomerular filtration rate (eGFR) \<25 ml/min
8. Life expectancy (according to the study physician's assessment) \<12 months.
9. Severe, unrepaired congenital heart defect that would prevent implantation of the sensor.
10. Severe valve vitium with planned intervention in the next 3 months
11. Presence of a mechanical right heart valve.
12. Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent.
13. Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program.
14. Women of childbearing age with a positive pregnancy test at the time of inclusion

Where this trial is running

Bad Friedrichshall and 32 other locations

• SLK-Kliniken GmbH - Klinikum am Plattenwald — Bad Friedrichshall, Germany (Recruiting)
• Kerckhoff-Klinik Forschungs GmbH — Bad Nauheim, Germany (Recruiting)
• Herz- und Diabeteszentrum NRW — Bad Oeynhausen, Germany (Recruiting)
• BG Unfallkrankenhaus Berlin — Berlin, Germany (Recruiting)
• Charité Universitätsmedizin (Campus Mitte, Campus Benjamin Franklin) — Berlin, Germany (Recruiting)
• Deutsches Herzzentrum Berlin — Berlin, Germany (Not_yet_recruiting)
• Praxis am Spreebogen — Berlin, Germany (Recruiting)
• Sana Klinikum Lichtenberg — Berlin, Germany (Recruiting)
• Klinikum Bielefeld — Bielefeld, Germany (Recruiting)
• Universitätsklinikum Bonn — Bonn, Germany (Recruiting)
• Klinikum Coburg — Coburg, Germany (Recruiting)
• St Johannes Hospital Dortmund — Dortmund, Germany (Recruiting)
• Praxisklinik Herz und Gefäße — Dresden, Germany (Recruiting)
• St. Georg Klinikum — Eisenach, Germany (Recruiting)
• Helios Klinikum Erfurt — Erfurt, Germany (Recruiting)
• St. Elisabeth Krankenhaus, Contilia Herz- und Gefäßzentrum — Essen, Germany (Recruiting)
• Universitätsklinikum Essen — Essen, Germany (Recruiting)
• Universitätsklinikum Frankfurt — Frankfurt, Germany (Recruiting)
• Universitätsklinikum Gießen — Gießen, Germany (Recruiting)
• Universitäres Herz- und Gefäßzentrum Hamburg — Hamburg, Germany (Recruiting)
• Medizinische Hochschule Hannover — Hannover, Germany (Recruiting)
• Westpfalz Klinikum — Kaiserslautern, Germany (Recruiting)
• Klinikum Karlsburg — Karlsburg, Germany (Recruiting)
• St. Vinzenz Hospital — Köln, Germany (Recruiting)
• Leipzig Heart Institute GmbH — Leipzig, Germany (Recruiting)
• Cardio Centrum Ludwigsburg-Bietigheim — Ludwigsburg, Germany (Recruiting)
• Klinikum Oldenburg — Oldenburg, Germany (Recruiting)
• Klinikum Vest — Recklinghausen, Germany (Recruiting)
• Cardio Consil Rostock — Rostock, Germany (Recruiting)
• Krankenhaus der Barmherzigen Brüder — Trier, Germany (Recruiting)
• Schwarzwald-Baar Klinikum — Villingen-Schwenningen, Germany (Recruiting)
• Rems-Murr Klinikum — Winnenden, Germany (Recruiting)
• Deutsches Zentrum für Herzinsuffizienz (DZHI) — Würzburg, Germany (Recruiting)

Study contacts

• Principal investigator: Stefan Störk, MD — Wuerzburg University Hospital
• Study coordinator: Stefan Störk, MD

Conditions Heart Failure