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Impact of Therapy Optimization on the Level of Biomarkers in Patients With Decompensated Heart Failure (MOLITOR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501981
First Posted: December 30, 2011
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brahms AG
Information provided by (Responsible Party):
Verena Tscholl, Charite University, Berlin, Germany
  Purpose

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:

  1. To evaluate the impact of guideline-recommended medication on biomarker levels during and following recompensation.
  2. To evaluate whether the trajectory of relevant biomarkers (MR-proANP, MR-proADM) is of relevance to guide medical therapy following decompensation.
  3. 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.
  4. To evaluate whether the trajectory of relevant biomarkers (copeptin, CT-pro-ET1) is of relevance to guide medical therapy following decompensation.

Condition
Decompensated Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Therapy Optimization on the Level of Biomarkers in Patients With Acute Decompensated and Decompensated Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Verena Tscholl, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • quality of life [ Time Frame: from study start (day 1) during hosptialisation until second year of follow up ]

    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.


  • Six-minute walk test distance [ Time Frame: from study start (day 1) during hosptialisation until second year of follow up ]
    Six-minute walk test distance will be performed at Visit 1-6 a s well as Follow-up after first and second year.

  • Echocardiographic parameters [ Time Frame: from study start (day 1) during hosptialisation until second year of follow up ]
    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.


Enrollment: 150
Study Start Date: February 2011
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with acute decompensated and decompensated chronic heart failure
Criteria

Inclusion Criteria:

  1. Male or female patients ≥ 18 years.
  2. Hospitalized for ADHF or decompensated chronic heart failure. Patients who develop ADHF while hospitalized for another reason are not eligible.
  3. 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;
  4. Able to begin study within 24 hours from presentation to the hospital, including time spent in the emergency department.
  5. Be adequately informed of the nature and risks of the study and give written informed consent prior to study start.

Exclusion Criteria:

  1. Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3x the upper limit of normal. at the institution's local laboratory.
  2. Cardiogenic shock.
  3. Temperature > 38°C (oral or equivalent), sepsis or active infection requiring IV antimicrobial treatment.
  4. ADHF due to significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 bpm or atrial fibrillation/flutter with ventricular response of > 150 bpm).
  5. Current or planned ultrafiltration, hemofiltration, or dialysis.
  6. 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.
  7. Any organ transplant recipient or patients currently listed or admitted for transplantation.
  8. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral valve filling patterns).
  9. Women who are pregnant or breastfeeding.
  10. Malignant disease with a life expectancy of less than two years.
  11. Autoimmune disease.
  12. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501981


Locations
Germany
Charité Campus Virchow Klinikum-Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Brahms AG
  More Information

Responsible Party: Verena Tscholl, Dr. med. univ., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01501981     History of Changes
Other Study ID Numbers: 20120211
First Submitted: March 30, 2011
First Posted: December 30, 2011
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by Verena Tscholl, Charite University, Berlin, Germany:
heart failure
MR-proANP
MR-proADM
decompensation
Copeptin
CT-proET1
NT-proBNP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases


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