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

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Device: CardioMEMSTM HF sensor - pulmonary artery pressure measurement

• Registration Number: NCT04398654
• Lead Sponsor: IHF GmbH - Institut für Herzinfarktforschung

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-21
• Study Start: 2020-10-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 554

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	CardioMEMSTM HF sensor - pulmonary artery pressure measurement	As in control group. In addition, in the intervention arm the CardioMEMSTM HF sensor implanted.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality	12 months	Rate of all-cause mortality
Major secondary endpoint: changes in disease-related quality of life	6 and 12 months	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.
Changes in generic health-related quality of life	6 and 12 months	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.
HF-related mortality	12 months	Rate of HF-related mortality
Cardiovascular Mortality	12 months	Rate of cardiovascular mortality
Non-serious Adverse Events	12 months	Rate of non-serious adverse events
Unplanned all-cause hospitalizations	12 months	Rate of all-cause hospitalisations
Unplanned HF-related hospitalizations	12 months	Rate of HF-related hospitalisations
Unplanned cardiovascular-related hospitalizations	12 months	Rate of cardiovascular-related hospitalisations
Unplanned hospitalizations, other	12 months	Number of days alive and out of hospital
Serious Adverse Events	12 months	Rate of serious adverse events
Symptoms of heart failure	12 months	Patient-reported symptoms of heart failure, measured by of the KCCQ Symptoms Score

Trial Locations

Locations (33)

St. Georg Klinikum; 🇩🇪 Eisenach, Germany

Universitäres Herz- und Gefäßzentrum Hamburg; 🇩🇪 Hamburg, Germany

Klinikum Karlsburg; 🇩🇪 Karlsburg, Germany

St. Elisabeth Krankenhaus, Contilia Herz- und Gefäßzentrum; 🇩🇪 Essen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsklinikum Gießen; 🇩🇪 Gießen, Germany

Praxisklinik Herz und Gefäße; 🇩🇪 Dresden, Germany

Leipzig Heart Institute GmbH; 🇩🇪 Leipzig, Germany

Krankenhaus der Barmherzigen Brüder; 🇩🇪 Trier, Germany

SLK-Kliniken GmbH - Klinikum am Plattenwald; 🇩🇪 Bad Friedrichshall, Germany

Kerckhoff-Klinik Forschungs GmbH; 🇩🇪 Bad Nauheim, Germany

BG Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Praxis am Spreebogen; 🇩🇪 Berlin, Germany

Charité Universitätsmedizin (Campus Mitte, Campus Benjamin Franklin); 🇩🇪 Berlin, Germany

Klinikum Bielefeld; 🇩🇪 Bielefeld, Germany

Sana Klinikum Lichtenberg; 🇩🇪 Berlin, Germany

Klinikum Coburg; 🇩🇪 Coburg, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

St Johannes Hospital Dortmund; 🇩🇪 Dortmund, Germany

Helios Klinikum Erfurt; 🇩🇪 Erfurt, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Westpfalz Klinikum; 🇩🇪 Kaiserslautern, Germany

St. Vinzenz Hospital; 🇩🇪 Köln, Germany

Cardio Centrum Ludwigsburg-Bietigheim; 🇩🇪 Ludwigsburg, Germany

Klinikum Oldenburg; 🇩🇪 Oldenburg, Germany

Klinikum Vest; 🇩🇪 Recklinghausen, Germany

Cardio Consil Rostock; 🇩🇪 Rostock, Germany

Rems-Murr Klinikum; 🇩🇪 Winnenden, Germany

Schwarzwald-Baar Klinikum; 🇩🇪 Villingen-Schwenningen, Germany

Deutsches Zentrum für Herzinsuffizienz (DZHI); 🇩🇪 Würzburg, Germany