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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398654
• Other study ID #: PASSPORT-HF
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: Stefan Störk, MD
• Phone: 093120146361
• Email: Stoerk_S[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 554
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Primary safety endpoint: device-related complications	Rate of Device / System related complications	12 months
Primary	Co-primary safety endpoint: sensor failure	Rate of sensor failures	12 months
Secondary	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
Secondary	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
Secondary	HF-related mortality	Rate of HF-related mortality	12 months
Secondary	Cardiovascular Mortality	Rate of cardiovascular mortality	12 months
Secondary	All-cause Mortality	Rate of all-cause mortality	12 months
Secondary	Unplanned HF-related hospitalizations	Rate of HF-related hospitalisations	12 months
Secondary	Unplanned cardiovascular-related hospitalizations	Rate of cardiovascular-related hospitalisations	12 months
Secondary	Unplanned all-cause hospitalizations	Rate of all-cause hospitalisations	12 months
Secondary	Unplanned hospitalizations, other	Number of days alive and out of hospital	12 months
Secondary	Non-serious Adverse Events	Rate of non-serious adverse events	12 months
Secondary	Serious Adverse Events	Rate of serious adverse events	12 months
Secondary	Symptoms of heart failure	Patient-reported symptoms of heart failure, measured by of the KCCQ Symptoms Score	12 months