Multi-center, randomized clinical trial to study the impact of in-hospital guidance for acutely decompensated heart failure treatment by predefined NT-proBNP targets (>30% reduction in NT-proBNP during admission) on the reduction of readmission rates and mortality

Completed

• Conditions: congestive heart failure; 10019280; acutely decompensated heart failure

• Registration Number: NL-OMON44072
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 362

Inclusion Criteria

1. Hospital admission because of clinically validated acutely decompensated heart failure.
2. Elevated NT-proBNP levels *1700 ng/L (*200 pmol/L) on hospital admission.
3. Written informed consent to participate in this study prior to any study procedures

Exclusion Criteria

1. Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV<1l/min.
2. Pulmonary embolism within 1 month prior to admission and pulmonary hypertension not caused by left ventricle dysfunction (LVD).
3. Patients undergoing Continue Ambulant Peritoneal Dialysis (CAPD)/ Haemodialysis patients.
4. Patients with planned Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI), Cardiac Resynchronization Therapy (CRT) and/or valvular surgery before admission (until one day before admission).
5. Patients with planned Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI), Cardiac Resynchronization Therapy (CRT) and/or valvular surgery during admission until the moment of randomization
6. Patient with a history of ST-segment-Elevated Myocardial Infarction (STEMI), CABG, PCI, CRT and/or valvular surgery within 1 month prior to admission.
7. Patients in cardiogenic shock at admission requiring invasive treatment.
8. Signed informed consent for any current interventional study.
9. Presence of severe non-cardiac related life-threatening disease before inclusion with an expected survival of less than 6 months after inclusion.
10. Mental of physical status not allowing written informed consent.
11. Unwillingness to give informed consent.
12. Circumstances that prevent follow-up (no permanent home address, transient, etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The differences between the group which received the conventional therapie and<br /><br>the intervention group, treated according to NT-proBNP levels in readmission<br /><br>and mortalitly in the first 180 days.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>.</p><br>