Serial BNP Measurements and Time to Disappearance of S3 in Goal-Directed Therapy of ADHF
Information source: University Hospital, Basel, Switzerland
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Heart Failure
Intervention: Early goal-directed therapy - Nitroglycerin Streuli®, Nitroderm TTS®, Triatec®, Atacand® (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University Hospital, Basel, Switzerland Official(s) and/or principal investigator(s):
Mueller Christian, MD, Principal Investigator, Affiliation: University Hospital, Basel, Switzerland
Overall contact:
Christian Mueller, MD, Phone: 0041-61-2655826, Email: muellerch@uhbs.ch
Summary
To test the hypotheses that an early goal-directed decrement of preload and afterload with a
target systolic blood pressure of 90-110 mmHg by aggressive vasodilatation in patients with
acute HF in the non-ICU setting will leads to a favourable course of BNP levels and to a
faster disappearance of S3.
Clinical Details
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Course of BNP
Secondary outcome: Time to disappearance of S3
Detailed description:
Background: Heart failure (HF) is a chronic and progressive illness resulting from a variety
of cardiac causes, including ischemic and valvular heart disease, dilatative cardiomyopathy
or hypertension. HF may also develop suddenly, particularly as a complication of acute
myocardial infarction or as an acute exacerbation in patients with previously compensated
chronic HF. Acute HF requires immediate treatment that centers on reducing myocardial oxygen
demand and augmenting forward blood flow by removal of excess fluid with diuretics and
reduction of preload and afterload with vasodilatators. B-type Natriuretic Peptide has been
shown to be very helpful in assessment of diagnosis, prognosis and severity of HF.
The third heart sound (S3) results from vigorous filling of the ventricle early in diastole
and is present in many normal, asymptomatic individuals below the age of 40. However, in
patients with symptoms consistent with HF, especially patients above the age of 40, the S3
is highly specific for HF Aim: To test the hypotheses that an early goal-directed decrement
of preload and afterload with a target systolic blood pressure of 90-110 mmHg by aggressive
vasodilatation in patients with acute HF in the non-ICU setting will leads to a faster
decrement of BNP levels and to a faster disappearance of S3.
Design: Prospective, randomized, controlled, open label, single centre, interventional
study Setting: University Hospital Basel Patients: Patients with acute HF not requiring ICU
admission
Patients admitted to the emergency department with acute HF will be randomized to:
- Early goal-directed preload and afterload decrement using a fixed therapy schedule
including sublingual and transdermal nitrates, and hydralazine, followed by rapid
up-titration of ACE-inhibitors or AT-receptor blockers to achieve maximal
vasodilatation with a target systolic blood pressure of 90-110 mmHg. All other elements
of treatment will be according to the current guidelines of the European Society of
Cardiology (ESC)
- Standard treatment of acute HF according to the current guidelines of the ESC.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Acute HF
- Age > 40 years
- Informed consent
Exclusion Criteria:
- Cardiopulmonary resuscitation < 7 days
- Cardiogenic shock, ST-elevation myocardial infarction, or other clinical conditions
that require immediate ICU admission or urgent PTCA
- Systolic blood pressure lower than 100 mmHg at presentation
- Primary rhythmogenic cause of acute decompensation (ventricular tachycardia, reentry
tachycardia, atrial fibrillation or atrial flutter with a ventricular rate exceeding
140 beats per minute)
- NSTEMI as primary diagnosis
- Severe aortic stenosis
- Adult congenital heart disease as primary cause of acute HF
- Hypertrophic obstructive cardiomyopathy
- Chronic kidney disease with creatinin levels > 250 µmol/l
- Bilateral renal artery stenosis
- Severe sepsis or other causes of high output failure
- Cirrhosis of the liver CHILD class C
- Previous adverse reactions to nitrates
Locations and Contacts
Christian Mueller, MD, Phone: 0041-61-2655826, Email: muellerch@uhbs.ch
University Hospital Basel, Basel 4032, Switzerland; Not yet recruiting
Christian Mueller, MD, Phone: 0041-61-2655826, Email: muellerch@uhbs.ch
Additional Information
Starting date: September 2007
Last updated: August 8, 2007
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