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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03105726
Other study ID # C-1421-14-05
Secondary ID
Status Completed
Phase N/A
First received April 4, 2017
Last updated April 25, 2017
Start date November 2010
Est. completion date January 2014

Study information

Verified date April 2017
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

End-stage heart failure (ESHF) represents a major burden in terms of quality of life, mortality and costs. The current practice in France is to treat patients with ESHF by a combination of drugs and lifestyle interventions before proposing heart transplant (HT) if there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in Germany, patients presenting with ESHF are preferentially managed by ventricular assist device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these two strategies in the management of ESHF and associated consumption of resources.


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date January 2014
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility Inclusion Criteria: All patients presenting with end-stage heart failure defined as:

- A left ventricular ejection fraction =25%

- Or an oxygen consumption peak < 14 mL/kg/min

- Or severe symptoms (NYHA class III or IV) despite optimal medical treatment

- Or a cardiogenic shock

Exclusion Criteria:

- Age over 70 years

- Active neoplasia

- Suspected or active systemic infection

- Body mass index =40 kg/m2

- Severe chronic obstruction pulmonary disease

- Evidence of intrinsic hepatic diseases defined as liver enzyme values = 5 times the upper limit of normal within 4 days before the randomisation, or biopsy proven liver cirrhosis

- Significant chronic renal impairment with persistent creatinine >2.5 or clearance < 25ml/min

- Pregnant or lactating female

- Patient under consideration for conventional revascularization procedures, therapeutic valvular repair, left ventricular procedure or cardiomyoplasty

- Presence of implanted mechanical aortic valve that will not be converted to bioprothesis at the time of ventricular assist device implantation

- Evidence of intrinsic hepatic diseases defined as liver enzyme values = 5 times the upper limit of normal, or biopsy proven liver cirrhosis

- Occurrence of stroke within 90 days or history of cerebrovascular disease with major (= 80%) extracranial or carotid stenosis documented by Doppler study

- Confirmation by neurologist of impairment of cognitive function, presence of Alzheimer's disease or any other form of irreversible dementia or both

- Major peripheral vascular disease accompanied by pain on rest or leg ulceration

- Recent history of psychiatric disease that is likely to impair compliance

- Drug or alcohol dependence

- Difficult social surroundings

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Joe Elie Salem

Outcome

Type Measure Description Time frame Safety issue
Primary Survival The primary outcome was comparison of survival at two years between the two treatment strategies two years
Secondary Resource consumption One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about resource consumption. Two years
Secondary Costs One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs. Two years
Secondary Costs versus survival One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs versus survival. Two years
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