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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimising Congestive Heart Failure Outpatient Clinic Project

NCT01671995

Heart Failure

COMPLETED NA

Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

NCT00514384

Acute Heart Failure

COMPLETED

Acute Congestive Heart Failure

NCT01885403

Acute Decompensated Heart Failure (ADHF) Acute Cardiogenic Pulmonary Edema (ACPE)

UNKNOWN NA

DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics

NCT04877652

Acute Decompensated Heart Failure

COMPLETED

Effect of Post Discharge Follow-up on Readmission Rates for Congestive Heart Failure Patients

NCT01529463

Congestive Heart Failure Systolic Dysfunction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decompensated Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No