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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Brahms AG
Information provided by (Responsible Party):
Verena Tscholl, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01501981
First received: March 30, 2011
Last updated: December 29, 2011
Last verified: December 2011
  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 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501981

Contacts
Contact: Hans Dirk Duengen, MD 0049-30-450-676 818 hans-dirk.duengen@charite.de

Locations
Germany
Charité Campus Virchow Klinikum-Medizinische Klinik mit Schwerpunkt Kardiologie Recruiting
Berlin, Germany, 13353
Contact: Elvis Tahirovic    0049-450-676 817    elvis.tahirovic@charite.de   
Principal Investigator: Hans Dirk Duengen, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Brahms AG
  More Information

No publications provided

Responsible Party: Verena Tscholl, Dr. med. univ., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01501981     History of Changes
Other Study ID Numbers: 20120211
Study First Received: March 30, 2011
Last Updated: December 29, 2011
Health Authority: Germany:'Ethical Committee Charité Berlin'

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014