Chronic Heart FailureNCT03020043
Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)
An observational study of Chronic Heart Failure, run by Johann Wolfgang Goethe University Hospital at 2 sites in Germany.
Trial summary
Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option. In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on mortality and morbidity in a routine clinical setting in Germany, the investigators initiated this multicenbtric registry. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 500 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2016to Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with New York Heart Association (NYHA) Class III with chronic heart failure (left and right ventricular heart failure, HFrEF, HFmrEF and HFpEF; +/- PH) , who had a hospitalisation for cardiac decompensation < 12 months
Who may be able to join
- Implantation of CardioMEMS successful
- Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe University)
Who cannot join
- Unwillingness to participate in the registry
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Goethe University
Frankfurt am Main, 60590
Birgit Assmus, MD, +49 69 6301 ext. 84690, birgit.assmus@kgu.de
Ester Herrmann, MD, +49 69 6301 ext. 84690, ester.herrmann@kgu.de
- Not yet recruiting
University Hospital Justus-Liebe University
Giessen, 35392
Birgit Assmus, MD, +49 641 985 ext. 42637, birgit.assmus@innere.med.uni-giessen.de
Ardeschir Ghofrani, MD, +49 641 985 ext. 42421, Ardeschir.Ghofrani@innere.med.uni-giessen.de
About this study
Official title: CardioMEMS Registry of the Frankfurt Heart Failure Center
Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option. In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on mortality and morbidity in a routine clinical setting in Germany, the investigators initiated this multicenbtric registry.
Read the detailed description
All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure parameters, lab values, medication and QoL as obtained on the regular outpatients visits in the department are entered into a registry-specific database.
The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL as well as on Guideline-recommended heart failure medication. In addition, it is planned to quantify the input in person time for telemonitoring.
- Conditions
- Chronic Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose
morbidity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgit Assmus, PD Dr., Johann Wolfgang Goethe University Hospital
- Investigators
- Birgit Assmus, MD, Principal investigator, Klinikum Goethe University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020043
- Sponsor's protocol ID
- FFM CardioMEMS Registry
- Status last verified
- Sep 2019
- First submitted
- 11 Jan 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Herrmann E, Ecke A, Herrmann E, Eissing N, Fichtlscherer S, Zeiher AM, Assmus B. Daily non-invasive haemodynamic telemonitoring for efficacy evaluation of MitraClip(R) implantation in patients with advanced systolic heart failure. ESC Heart Fail. 2018 Oct;5(5):780-787. doi: 10.1002/ehf2.12303. Epub 2018 Jun 12.
PubMed 29893475Herrmann E, Fichtlscherer S, Hohnloser SH, Zeiher AM, Assmus B. [Implantable sensors for outpatient assessment of ventricular filling pressure in advanced heart failure : Which telemonitoring design is optimal?]. Herzschrittmacherther Elektrophysiol. 2016 Dec;27(4):371-377. doi: 10.1007/s00399-016-0472-0. Epub 2016 Nov 14. German.
PubMed 27844194Herrmann E, Ecke A, Fichtlscherer S, Zeiher AM, Assmus B. [Pulmonary artery pressure sensor for ambulatory assessment of ventricular filling pressure in advanced heart failure : What should be considered for the follow-up care?]. Herzschrittmacherther Elektrophysiol. 2018 Dec;29(4):393-400. doi: 10.1007/s00399-018-0597-4. Epub 2018 Oct 10. German.
PubMed 30306304
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioMEMS Registry of the Frankfurt Heart Failure Center
- ClinicalTrials.gov ID
- NCT03020043
- Acronym / sponsor ID
- FFM CardioMEMS Registry
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option. In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on mortality and morbidity in a routine clinical setting in Germany, the investigators initiated this multicenbtric registry.
Detailed description
All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure parameters, lab values, medication and QoL as obtained on the regular outpatients visits in the department are entered into a registry-specific database.
The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL as well as on Guideline-recommended heart failure medication. In addition, it is planned to quantify the input in person time for telemonitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with New York Heart Association (NYHA) Class III with chronic heart failure (left and right ventricular heart failure, HFrEF, HFmrEF and HFpEF; +/- PH) , who had a hospitalisation for cardiac decompensation < 12 months
Key inclusion criteria (2 listed)
- Implantation of CardioMEMS successful
- Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe University)
Key exclusion criteria (1 listed)
- Unwillingness to participate in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose
Time frame: 5 years
morbidity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Results publication: PubMed 29893475Herrmann E, Ecke A, Herrmann E, Eissing N, Fichtlscherer S, Zeiher AM, Assmus B. Daily non-invasive haemodynamic telemonitoring for efficacy evaluation of MitraClip(R) implantation in patients with advanced systolic heart failure. ESC Heart Fail. 2018 Oct;5(5):780-787. doi: 10.1002/ehf2.12303. Epub 2018 Jun 12.
- Results publication: PubMed 27844194Herrmann E, Fichtlscherer S, Hohnloser SH, Zeiher AM, Assmus B. [Implantable sensors for outpatient assessment of ventricular filling pressure in advanced heart failure : Which telemonitoring design is optimal?]. Herzschrittmacherther Elektrophysiol. 2016 Dec;27(4):371-377. doi: 10.1007/s00399-016-0472-0. Epub 2016 Nov 14. German.
- Results publication: PubMed 30306304Herrmann E, Ecke A, Fichtlscherer S, Zeiher AM, Assmus B. [Pulmonary artery pressure sensor for ambulatory assessment of ventricular filling pressure in advanced heart failure : What should be considered for the follow-up care?]. Herzschrittmacherther Elektrophysiol. 2018 Dec;29(4):393-400. doi: 10.1007/s00399-018-0597-4. Epub 2018 Oct 10. German.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Assmus, MD principal investigator
Klinikum Goethe University Frankfurt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Johann Wolfgang Goethe University Hospital at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit Assmus, MD (+49 69 6301 ext. 84690, birgit.assmus@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03020043, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.