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

NCT04398654 | Recruiting DMC

• 1 other identifier: PASSPORT-HF
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 33

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Major secondary endpoint: changes in disease-related quality of life

  6 and 12 months

• Changes in generic health-related quality of life

  6 and 12 months

• HF-related mortality

  12 months

• Cardiovascular Mortality

  12 months

• All-cause Mortality

  12 months

Study Arms (2)

Control Group

NO INTERVENTION

Monitoring and therapy adjustment within the scope of the basic care described in the clinical trial plan.

Intervention Group

ACTIVE COMPARATOR

As in control group. In addition, in the intervention arm the CardioMEMSTM HF sensor implanted.

Device: CardioMEMSTM HF sensor - pulmonary artery pressure measurement

Interventions

CardioMEMSTM HF sensor - pulmonary artery pressure measurement DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• IHF GmbH - Institut für Herzinfarktforschung: lead

Study Sites (33)

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. Vinzenz Hospital

Cologne, 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

Hanover, Germany

RECRUITING

Westpfalz Klinikum

Kaiserslautern, Germany

RECRUITING

Klinikum Karlsburg

Karlsburg, 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, 97080, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 35246723 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Stefan Störk, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Störk, MD

CONTACT

093120146361; Stoerk_S@ukw.de

Claas Christoph, PhD

CONTACT

claas@ihf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 21, 2020
• Study Start: October 2, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

DE (33)