Active — Not RecruitingNot Applicable

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

Germany554 participantsStarted 2020-10-02

Plain-language 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. In addition, data on longtime-mortality is being collected towards the end of the study for all study participants.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms.
✓. Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
✓. 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.
✓. 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.

Exclusion criteria

What they're measuring

Primary efficacy endpoint: composite of unplanned HF-related rehospitalisations and all-cause death

Timeframe: 12 months

Primary safety endpoint: device-related complications

Timeframe: 12 months

Co-primary safety endpoint: sensor failure

Timeframe: 12 months

Trial details

NCT IDNCT04398654

SponsorIHF GmbH - Institut für Herzinfarktforschung

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-25

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms.
✓. Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
✓. 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.
✓. 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.