Clinical trial NCT04398654: Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes
Official title: Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 endpoints, safety and quality of life. The target population consists of heart failure (HF) patients who have been predominantly in New York Heart Association (NYHA) Stage III for the past 30 days and at least once in the past 12 months for HF were admitted to hospital. All patients receive basic care, which is based on structured telephone contact (between the care center, patient and family doctor) to optimize guideline compliant therapy. In the intervention group a PA pressure sensor is (CardioMEMS™-HF Sensor) implanted. These patients are structured by specially trained non-medical personnel aftercare with additional inclusion of the PA pressure values: adjusted to the basis of the information collected in PA monitoring the therapy is optimized. The follow-up period until the primary endpoint is 12 months.


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

Primary outcomes:
measure: Primary efficacy endpoint: composite of unplanned HF-related rehospitalisations and all-cause death
timeFrame: 12 months
measure: Primary safety endpoint: device-related complications
timeFrame: 12 months
measure: Co-primary safety endpoint: sensor failure
timeFrame: 12 months
Secondary outcomes:
measure: Major secondary endpoint: changes in disease-related quality of life
timeFrame: 6 and 12 months
measure: Changes in generic health-related quality of life
timeFrame: 6 and 12 months
measure: HF-related mortality
timeFrame: 12 months
measure: Cardiovascular Mortality
timeFrame: 12 months
measure: All-cause Mortality
timeFrame: 12 months
measure: Unplanned HF-related hospitalizations
timeFrame: 12 months
measure: Unplanned cardiovascular-related hospitalizations
timeFrame: 12 months
measure: Unplanned all-cause hospitalizations
timeFrame: 12 months
measure: Unplanned hospitalizations, other
timeFrame: 12 months
measure: Non-serious Adverse Events
timeFrame: 12 months
measure: Serious Adverse Events
timeFrame: 12 months
measure: Symptoms of heart failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken GmbH - Klinikum am Plattenwald
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik Forschungs GmbH
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: BG Unfallkrankenhaus Berlin
city: Berlin
country: Germany
facility: Charité Universitätsmedizin (Campus Mitte, Campus Benjamin Franklin)
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Berlin
country: Germany
facility: Praxis am Spreebogen
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Dortmund
country: Germany
facility: St Johannes Hospital Dortmund
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefäße
city: Eisenach
country: Germany
facility: St. Georg Klinikum
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: St. Elisabeth Krankenhaus, Contilia Herz- und Gefäßzentrum
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kaiserslautern
country: Germany
facility: Westpfalz Klinikum
city: Karlsburg
country: Germany
facility: Klinikum Karlsburg
city: Köln
country: Germany
facility: St. Vinzenz Hospital
city: Leipzig
country: Germany
facility: Leipzig Heart Institute GmbH
city: Ludwigsburg
country: Germany
facility: Cardio Centrum Ludwigsburg-Bietigheim
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Recklinghausen
country: Germany
facility: Klinikum Vest
city: Rostock
country: Germany
facility: Cardio Consil Rostock
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum
city: Winnenden
country: Germany
facility: Rems-Murr Klinikum
city: Würzburg
country: Germany
facility: Deutsches Zentrum für Herzinsuffizienz (DZHI)
Study officials:
affiliation: Wuerzburg University Hospital
name: Stefan Störk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stork S, Bernhardt A, Bohm M, Brachmann J, Dagres N, Frantz S, Hindricks G, Kohler F, Zeymer U, Rosenkranz S, Angermann C, Assmus B. Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial. Clin Res Cardiol. 2022 Nov;111(11):1245-1255. doi: 10.1007/s00392-022-01987-3. Epub 2022 Mar 4.