Decompensated Heart FailureMOLITORNCT01501981
Impact of Therapy Optimization on the Level of Biomarkers in Patients With Decompensated Heart Failure
An observational study of Decompensated Heart Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In this pilot, investigator-initiated multi-centre, multinational, observational study the investigators would like to examine the impact of therapy optimization on the level of biomarkers in patients with acute decompensated and decompensated chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Heart Failure
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute decompensated and decompensated chronic heart failure
Who may be able to join
- Male or female patients ≥ 18 years.
- Hospitalized for ADHF or decompensated chronic heart failure. Patients who develop ADHF while hospitalized for another reason are not eligible.
- The underlying primary etiology for decompensation should be cardiac rather than pulmonary disease. For this study, all of the following must be observable at the time of screening:
- Dyspnea at rest (sitting or supine) or with minimal exertion (such as talking, eating, etc.) - NYHA III/IV;
- Pulmonary congestion on physical examination or chest x-ray;
- Able to begin study within 24 hours from presentation to the hospital, including time spent in the emergency department.
- Be adequately informed of the nature and risks of the study and give written informed consent prior to study start.
Who cannot join
- Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3x the upper limit of normal. at the institution's local laboratory.
- Cardiogenic shock.
- Temperature > 38°C (oral or equivalent), sepsis or active infection requiring IV antimicrobial treatment.
- ADHF due to significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 bpm or atrial fibrillation/flutter with ventricular response of > 150 bpm).
- Current or planned ultrafiltration, hemofiltration, or dialysis.
- Significant pulmonary disease (history of oral daily steroid dependency, history of CO2 retention or need for intubation for acute exacerbation, or currently receiving IV steroids), or thoracic cage injury which compromises breathing.
Show all 12Show fewer
- Any organ transplant recipient or patients currently listed or admitted for transplantation.
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral valve filling patterns).
- Women who are pregnant or breastfeeding.
- Malignant disease with a life expectancy of less than two years.
- Autoimmune disease.
- Any condition or treatment of a condition which, in the opinion of the investigator, could interfere with the conduct of the study, or which would unacceptably increase the risk of the patient's participation in the study. This may include, but is not limited to, alcoholism, drug dependency or abuse, other severe mental disorders, epilepsy, or any unexplained episodes of syncope.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Campus Virchow Klinikum-Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, 13353
About this study
Official title: Impact of Therapy Optimization on the Level of Biomarkers in Patients With Acute Decompensated and Decompensated Chronic Heart Failure
In this pilot, investigator-initiated multi-centre, multinational, observational study the investigators would like to examine the impact of therapy optimization on the level of biomarkers in patients with acute decompensated and decompensated chronic heart failure.
The primary objective is to determine the best time point for measuring biomarker levels during therapy optimization in patients with decompensation to predict clinical outcomes such as mortality, hospitalisation, and quality of life.
Read more
Secondary objectives are:
- To evaluate the impact of guideline-recommended medication on biomarker levels during and following recompensation.
- To evaluate whether the trajectory of relevant biomarkers (MR-proANP, MR-proADM) is of relevance to guide medical therapy following decompensation.
- To evaluate whether the degree of biomarker change (e.g. slow versus rapid change) is of relevance with regard to hemodynamic stability and cardiovascular events such as hospitalisation.
- To evaluate whether the trajectory of relevant biomarkers (copeptin, CT-pro-ET1) is of relevance to guide medical therapy following decompensation.
- Conditions
- Decompensated Heart Failure
- Keywords
- heart failure, MR-proANP, MR-proADM, decompensation, Copeptin, CT-proET1, NT-proBNP
- Medical subject headings
- Heart Failure, Diabetes Insipidus
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first event - all cause death - cardiovascular death - all cause hospitalisation - cardiovascular hospitalisation - hospitalization for heart failure
Time to first event
- all cause death
- cardiovascular death
- all cause hospitalisation
- cardiovascular hospitalisation
- hospitalization for heart failure
Measured: from study start (day 1) during hosptialisation until second year of follow up
Secondary outcomes (3)
quality of life
The EuroQoL EQ-5D quality of life scale consists of 5 items scaled 1 to 3 reflecting different dimensions of quality of life and a visual analog scale measuring overall self-rated health.
The Short Form 36 Health Survey. The Hospital Anxiety and Depression Scale (HADS) consists of 14 items measuring symptoms of anxiety and depression in physically ill patients.
The ENRICHD Social Support Instrument (ESSI) has been developed as a brief tool for measuring perceived social support in the large randomized ENRICHD study.
Measured: from study start (day 1) during hosptialisation until second year of follow up
Six-minute walk test distance
Six-minute walk test distance will be performed at Visit 1-6 a s well as Follow-up after first and second year.
Measured: from study start (day 1) during hosptialisation until second year of follow up
Echocardiographic parameters
Echocardiography (done within the first seven days from the day of entering the study): dimensions of the left ventricle, wall thickness and EF per Simpson (if it is not possible to determine EF per Simpson in particular cases due to very limited sound conditions, then it could be visually assessed by an experienced echocardiographer), diastolic function of the left ventricle per the American Society of Echocardiography (ASE): mitral Doppler, tissue Doppler, pulmonary vein Doppler.
Measured: from study start (day 1) during hosptialisation until second year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionJun 2014
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 Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Brahms AG
- Responsible party
- Principal investigator, Verena Tscholl, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501981
- Sponsor's protocol ID
- 20120211
- Acronym
- MOLITOR
- Status last verified
- Jul 2017
- First submitted
- 30 Mar 2011
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Veskovic J, Cvetkovic M, Tahirovic E, Zdravkovic M, Apostolovic S, Kosevic D, Loncar G, Obradovic D, Matic D, Ignjatovic A, Cvetkovic T, Posch MG, Radenovic S, Ristic AD, Dokic D, Milosevic N, Panic N, Dungen HD. Depression, anxiety, and quality of life as predictors of rehospitalization in patients with chronic heart failure. BMC Cardiovasc Disord. 2023 Oct 27;23(1):525. doi: 10.1186/s12872-023-03500-8.
PubMed 37891464Zelenak C, Chavanon ML, Tahirovic E, Trippel TD, Tscholl V, Stroux A, Veskovic J, Apostolovic S, Obradovic D, Zdravkovic M, Loncar G, Stork S, Herrmann-Lingen C, Dungen HD. Early NT-proBNP and MR-proANP associated with QoL 1 year after acutely decompensated heart failure: secondary analysis from the MOLITOR trial. Biomark Med. 2019 Dec;13(17):1493-1507. doi: 10.2217/bmm-2019-0083. Epub 2019 Oct 29.
PubMed 31659915Dungen HD, Tscholl V, Obradovic D, Radenovic S, Matic D, Musial Bright L, Tahirovic E, Marx A, Inkrot S, Hashemi D, Veskovic J, Apostolovic S, von Haehling S, Doehner W, Cvetinovic N, Lainscak M, Pieske B, Edelmann F, Trippel T, Loncar G. Prognostic performance of serial in-hospital measurements of copeptin and multiple novel biomarkers among patients with worsening heart failure: results from the MOLITOR study. ESC Heart Fail. 2018 Apr;5(2):288-296. doi: 10.1002/ehf2.12231. Epub 2018 Feb 24.
PubMed 29476612
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapy Optimization on the Level of Biomarkers in Patients With Acute Decompensated and Decompensated Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01501981
- Acronym / sponsor ID
- MOLITOR / 20120211
- Conditions
- Decompensated Heart Failure
- Keywords
- heart failure, MR-proANP, MR-proADM, decompensation, Copeptin, CT-proET1, NT-proBNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Brahms AG
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Dec 2011 (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.
In this pilot, investigator-initiated multi-centre, multinational, observational study the investigators would like to examine the impact of therapy optimization on the level of biomarkers in patients with acute decompensated and decompensated chronic heart failure.
The primary objective is to determine the best time point for measuring biomarker levels during therapy optimization in patients with decompensation to predict clinical outcomes such as mortality, hospitalisation, and quality of life.
Secondary objectives are:
- To evaluate the impact of guideline-recommended medication on biomarker levels during and following recompensation.
- To evaluate whether the trajectory of relevant biomarkers (MR-proANP, MR-proADM) is of relevance to guide medical therapy following decompensation.
- To evaluate whether the degree of biomarker change (e.g. slow versus rapid change) is of relevance with regard to hemodynamic stability and cardiovascular events such as hospitalisation.
- To evaluate whether the trajectory of relevant biomarkers (copeptin, CT-pro-ET1) is of relevance to guide medical therapy following decompensation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute decompensated and decompensated chronic heart failure
Key inclusion criteria (7 listed)
- Male or female patients ≥ 18 years.
- Hospitalized for ADHF or decompensated chronic heart failure. Patients who develop ADHF while hospitalized for another reason are not eligible.
- The underlying primary etiology for decompensation should be cardiac rather than pulmonary disease. For this study, all of the following must be observable at the time of screening:
- Able to begin study within 24 hours from presentation to the hospital, including time spent in the emergency department.
- Be adequately informed of the nature and risks of the study and give written informed consent prior to study start.
Key exclusion criteria (12 listed)
- Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3x the upper limit of normal. at the institution's local laboratory.
- Cardiogenic shock.
- Temperature > 38°C (oral or equivalent), sepsis or active infection requiring IV antimicrobial treatment.
- ADHF due to significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 bpm or atrial fibrillation/flutter with ventricular response of > 150 bpm).
- Current or planned ultrafiltration, hemofiltration, or dialysis.
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
Time to first event - all cause death - cardiovascular death - all cause hospitalisation - cardiovascular hospitalisation - hospitalization for heart failure
Time frame: from study start (day 1) during hosptialisation until second year of follow up
Time to first event * all cause death * cardiovascular death * all cause hospitalisation * cardiovascular hospitalisation * hospitalization for heart failure
3 secondary outcomes
quality of life
Time frame: from study start (day 1) during hosptialisation until second year of follow up
Six-minute walk test distance
Time frame: from study start (day 1) during hosptialisation until second year of follow up
Echocardiographic parameters
Time frame: from study start (day 1) during hosptialisation until second year of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 37891464Veskovic J, Cvetkovic M, Tahirovic E, Zdravkovic M, Apostolovic S, Kosevic D, Loncar G, Obradovic D, Matic D, Ignjatovic A, Cvetkovic T, Posch MG, Radenovic S, Ristic AD, Dokic D, Milosevic N, Panic N, Dungen HD. Depression, anxiety, and quality of life as predictors of rehospitalization in patients with chronic heart failure. BMC Cardiovasc Disord. 2023 Oct 27;23(1):525. doi: 10.1186/s12872-023-03500-8.
- Derived from this study: PubMed 31659915Zelenak C, Chavanon ML, Tahirovic E, Trippel TD, Tscholl V, Stroux A, Veskovic J, Apostolovic S, Obradovic D, Zdravkovic M, Loncar G, Stork S, Herrmann-Lingen C, Dungen HD. Early NT-proBNP and MR-proANP associated with QoL 1 year after acutely decompensated heart failure: secondary analysis from the MOLITOR trial. Biomark Med. 2019 Dec;13(17):1493-1507. doi: 10.2217/bmm-2019-0083. Epub 2019 Oct 29.
- Derived from this study: PubMed 29476612Dungen HD, Tscholl V, Obradovic D, Radenovic S, Matic D, Musial Bright L, Tahirovic E, Marx A, Inkrot S, Hashemi D, Veskovic J, Apostolovic S, von Haehling S, Doehner W, Cvetinovic N, Lainscak M, Pieske B, Edelmann F, Trippel T, Loncar G. Prognostic performance of serial in-hospital measurements of copeptin and multiple novel biomarkers among patients with worsening heart failure: results from the MOLITOR study. ESC Heart Fail. 2018 Apr;5(2):288-296. doi: 10.1002/ehf2.12231. Epub 2018 Feb 24.
Related trials for Decompensated Heart Failure
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompensated Heart Failure, run by Charite University, Berlin, Germany at 1 site 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first event - all cause death - cardiovascular death - all cause hospitalisation - cardiovascular hospitalisation - hospitalization for heart failure (time frame: from study start (day 1) during hosptialisation until second year of follow up). 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 NCT01501981, 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 25 Jul 2017.