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Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure


N/A
N/A
N/A
Not Enrolling
Both
Chronic Heart Failure

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Trial Information

Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure

Inclusion Criteria


Patients with a confirmed diagnosis in accordance with the criteria proposed by the
European Society of Cardiology and with NYHA III-IV symptoms. And at least one of
following criteria;

1. At least one episode of worsening heart failure that resolved with injection /
infusion of diuretics or the addition of other heart failure treatment in the last 6
months and regarded optimally treated according to the responsible physician.

2. Need for infusions-treatment.

3. Chronic poor quality of life (VAS < 50)

4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body
weight within the last 6-12 months)

5. less than one year life expectancy.

Exclusion Criteria:

Ineligible are patients:

1. who do not want to participate in the study;

2. with severe communication problems;

3. with severe dementia;

4. with other serious disease in which heart failure is of secondary importance;

5. with other life-threatening illness as the primary diagnosis with expected short
survival;

6. when the Primary Care Center which is responsible for patient care is geographically
located from more than 30 km radius outside the hospital; and

7. participating in another clinical trial. -

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks

Outcome Time Frame:

baseline and after 4, 16 and 24 weeks

Safety Issue:

No

Authority:

Sweden: Regional Ethical Review Board

Study ID:

HOPE001

NCT ID:

NCT01304381

Start Date:

January 2011

Completion Date:

April 2013

Related Keywords:

  • Chronic Heart Failure
  • Heart failure
  • Palliative care
  • Integrated care
  • Heart Failure

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