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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: CardioMEMSTM HF sensor - pulmonary artery pressure measurement

• Study Type: Interventional
• Enrollment (Anticipated): 554
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claas Christoph, PhD; Email: claas@ihf.de

Study Locations

• Germany
  • Bad Friedrichshall, Germany
    • Recruiting
    • SLK-Kliniken GmbH - Klinikum am Plattenwald
  • Bad Nauheim, Germany
    • Recruiting
    • Kerckhoff-Klinik Forschungs GmbH
  • Bad Oeynhausen, Germany
    • Recruiting
    • Herz- und Diabeteszentrum NRW
  • Berlin, Germany
    • Not yet recruiting
    • Deutsches Herzzentrum Berlin
  • Berlin, Germany
    • Recruiting
    • BG Unfallkrankenhaus Berlin
  • Berlin, Germany
    • Recruiting
    • Charité Universitätsmedizin (Campus Mitte, Campus Benjamin Franklin)
  • Berlin, Germany
    • Recruiting
    • Praxis am Spreebogen
  • Berlin, Germany
    • Recruiting
    • Sana Klinikum Lichtenberg
  • Bielefeld, Germany
    • Recruiting
    • Klinikum Bielefeld
  • Bonn, Germany
    • Recruiting
    • Universitätsklinikum Bonn
  • Coburg, Germany
    • Recruiting
    • Klinikum Coburg
  • Dortmund, Germany
    • Recruiting
    • St Johannes Hospital Dortmund
  • Dresden, Germany
    • Recruiting
    • Praxisklinik Herz und Gefäße
  • Eisenach, Germany
    • Recruiting
    • St. Georg Klinikum
  • Erfurt, Germany
    • Recruiting
    • Helios Klinikum Erfurt
  • Essen, Germany
    • Recruiting
    • Universitätsklinikum Essen
  • Essen, Germany
    • Recruiting
    • St. Elisabeth Krankenhaus, Contilia Herz- und Gefäßzentrum
  • Frankfurt, Germany
    • Recruiting
    • Universitatsklinikum Frankfurt
  • Gießen, Germany
    • Recruiting
    • Universitätsklinikum Gießen
  • Hamburg, Germany
    • Recruiting
    • Universitäres Herz- und Gefäßzentrum Hamburg
  • Hannover, Germany
    • Recruiting
    • Medizinische Hochschule Hannover
  • Kaiserslautern, Germany
    • Recruiting
    • Westpfalz Klinikum
  • Karlsburg, Germany
    • Recruiting
    • Klinikum Karlsburg
  • Köln, Germany
    • Recruiting
    • St. Vinzenz Hospital
  • Leipzig, Germany
    • Recruiting
    • Leipzig Heart Institute GmbH
  • Ludwigsburg, Germany
    • Recruiting
    • Cardio Centrum Ludwigsburg-Bietigheim
  • Oldenburg, Germany
    • Recruiting
    • Klinikum Oldenburg
  • Recklinghausen, Germany
    • Recruiting
    • Klinikum Vest
  • Rostock, Germany
    • Recruiting
    • Cardio Consil Rostock
  • Trier, Germany
    • Recruiting
    • Krankenhaus der Barmherzigen Brüder
  • Villingen-Schwenningen, Germany
    • Recruiting
    • Schwarzwald-Baar Klinikum
  • Winnenden, Germany
    • Recruiting
    • Rems-Murr Klinikum
  • Würzburg, Germany, 97080
    • Recruiting
    • Deutsches Zentrum für Herzinsuffizienz (DZHI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Monitoring and therapy adjustment within the scope of the basic care described in the clinical trial plan.
Active Comparator: Intervention Group; As in control group. In addition, in the intervention arm the CardioMEMSTM HF sensor implanted.	Device: CardioMEMSTM HF sensor - pulmonary artery pressure measurement; CardioMEMSTM HF sensor implantation to meassure pulmonary artery pressure. Evaluation of the pressure curves by telemetric transmission and coordination of necessary adjustments of the therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy endpoint: composite of unplanned HF-related rehospitalisations and all-cause death	Composite endpoint of number of unplanned HF-related rehospitalisations or all-cause death	12 months
Primary safety endpoint: device-related complications	Rate of Device / System related complications	12 months
Co-primary safety endpoint: sensor failure	Rate of sensor failures	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major secondary endpoint: changes in disease-related quality of life	Change in quality of life score after 6 and 12 month measured by Kansas City Cardiomyopathy questionnaire. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	6 and 12 months
Changes in generic health-related quality of life	Change in Quality of Life score after 6 and 12 month measures by EQ-5D questionnaire. The EQ-5D-5L descriptive system comprises the five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension (1 - 5, where higher scores indicate more severe problems). The EQ VAS records the respondent's overall current health on a vertical visual analogue scale (0-100), where the endpoints are labelled 'The best health you can imagine - 100' and 'The worst health you can imagine - 0'. The EQ VAS provides a quantitative measure of the patient's perception of their overall health.	6 and 12 months
HF-related mortality	Rate of HF-related mortality	12 months
Cardiovascular Mortality	Rate of cardiovascular mortality	12 months
All-cause Mortality	Rate of all-cause mortality	12 months
Unplanned HF-related hospitalizations	Rate of HF-related hospitalisations	12 months
Unplanned cardiovascular-related hospitalizations	Rate of cardiovascular-related hospitalisations	12 months
Unplanned all-cause hospitalizations	Rate of all-cause hospitalisations	12 months
Unplanned hospitalizations, other	Number of days alive and out of hospital	12 months
Non-serious Adverse Events	Rate of non-serious adverse events	12 months
Serious Adverse Events	Rate of serious adverse events	12 months
Symptoms of heart failure	Patient-reported symptoms of heart failure, measured by of the KCCQ Symptoms Score	12 months

Collaborators and Investigators

• Sponsor: IHF GmbH - Institut für Herzinfarktforschung

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Anticipated): June 30, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PASSPORT-HF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No