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

July 22, 2017 updated by: Verena Tscholl, Charite University, Berlin, Germany

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow Klinikum-Medizinische Klinik mit Schwerpunkt Kardiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with acute decompensated and decompensated chronic heart failure

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from study start (day 1) during hosptialisation until second year of follow up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Brahms AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (Estimate)

December 30, 2011

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 22, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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