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Goal-directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study (GALACTIC)

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ClinicalTrials.gov Identifier: NCT00512759
Recruitment Status : Active, not recruiting
First Posted : August 8, 2007
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland

Brief Summary:
The purpose of this study is to determine whether 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 is safe, and leads to a better clinical and economical outcome

Condition or disease Intervention/treatment Phase
Acute Heart Failure Drug: Goal-directed preload and afterload decrement Phase 4

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. The aging of our population and the higher number of patients surviving acute myocardial infarctions have lead to a dramatic increase in the incidence and prevalence of HF, and obviously also on total cost burden of the disease. For multiple reasons including need for restrictive use of the limited number of ICU hospital beds the vast majority of elderly patients with acute HF are treated in a non-ICU setting. Unfortunately, the optimal treatment of acute HF in the non-ICU setting is not well defined. Pathophysiological considerations and preliminary data from the ICU setting suggest that aggressive venous and arterial vasodilation may improve short and long-term outcome.

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 is safe, and leads to a better clinical and economical outcome

Methods:

Design: Prospective, randomized, controlled, open label, 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.

Clinical Significance: Despite the clinical and economical importance of acute HF, the optimal treatment of acute HF is ill-defined. We strongly believe that our novel therapeutic strategy will significantly reduce morbidity, length of hospitalisation, and possibly mortality of affected patients. This would represent a first major step for an evidence-based management of this common condition. Documenting medical and economic benefit of a simple, safe, and inexpensive medical therapy in a randomised controlled clinical trial would provide evidence-based care for the majority of patients presenting with acute HF worldwide. All drugs applied in our strategy are off-patent and therefore relatively low-cost. Successful implication of our treatment algorithm has the potential to significantly reduce treatment costs.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Goal-Directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study (GALACTIC)
Actual Study Start Date : September 2007
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
No Intervention: Standard of care
Standard of care of acute decompensated heart failure will be according to the current guidelines of the European Society of Cardiology (ESC).
Experimental: Intervention
Early goal-directed preload and afterload decrement using a fixed therapy schedule including sublingual or nitrospray and transdermal nitrates together with hydralazine, followed by rapid up-titration of ACE-inhibitors , AT-receptor blockers or neprilysin inhibitors/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)
Drug: Goal-directed preload and afterload decrement
Early goal-directed preload and afterload decrement with a target systolic blood pressure (RR) of 90-110 mmHg for the entire hospitalization using sublingual nitrates (Nitroglycerin Streuli®) or nitrospray (Corangin Nitrospray®) transdermal nitrates (Nitroderm TTS 10®), ACE-inhibitors (Triatec®) and/or ARB (Atacand®).
Other Names:
  • Nitroglycerin Streuli®
  • Nitroderm TTS 10®
  • Triatec®
  • Atacand®
  • Corangin Nitrospray®




Primary Outcome Measures :
  1. Death or re-hospitalization from HF [ Time Frame: 180 days ]
    Death or re-hospitalization due to heart failure at 180 days


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 180 days ]
    All-cause mortality at 180 days

  2. HF re-hospitalization [ Time Frame: 180 days ]
    Re-hospitalization due to heart failure at 180 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute HF expressed by acute dyspnea New York Heart Association (NYHA) class III or IV, and a BNP-level ≥ 500 pg/ml. The diagnosis of acute HF is additionally based on typical symptoms and clinical findings, supported by appropriate investigations such as ECG, chest X-ray, and Doppler-echocardiography as recommended by current ESC guidelines on the diagnosis and treatment of acute HF

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512759


Locations
Brazil
Hospital Sao Paolo
São Paulo, Brazil, 04024-002
Bulgaria
5-th Multifunctional Hospital for Active Treatment
Sofia, Bulgaria
National Transport Hospital "Tsar Boris III"
Sofia, Bulgaria
University Hospital "Tsaritsa Joanna-ISUL"
Sofia, Bulgaria
Germany
University Hospital Mainz
Mainz, Germany, 55131
Nuremberg Hospital
Nuremberg, Germany, 90419
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Switzerland
University Hospital Basel
Basel, BS, Switzerland, 4031
Kantonsspital Aarau
Aarau, Switzerland, 5001
Kantonsspital Luzern
Luzern, Switzerland, 6000
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christian Mueller, MD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Müller, MD, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00512759     History of Changes
Other Study ID Numbers: GALACTIC
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Nitroglycerin
Candesartan cilexetil
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action