Integrated Cardiac Care & Palliative Homecare for Patients With Severe

Status Completed

Clinical Trial Summary

Patients with severe heart failure have as many symptoms as many patients with cancer but yet do not have equal access to supportive and palliative care. They have an unpredictable course of illness, which makes difficult to judge when the palliative stage has been reached. The Heart failure and Palliative care Programme is a three-year project in Sweden financed by the Swedish Association of Local Authorities and Regions (SALAR). The overall aim is to develop, implement and evaluate a model that integrates cardiac care and palliative advanced home care for patients with severe chronic heart failure. The primary aim is to study the effects on patients' symptom burden, quality of life and activities of daily living. A randomized controlled clinical study is planned.

Patients (n=62) 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 will be included;

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 The participants will be randomized to intervention or control group. The intervention consist of a multidisciplinary approach and collaboration between specialist palliative and heart failure (HF) caregivers, in a shared structured person-centred and identity-promoting care at home during six months. Usual care is performed for the control group.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01304381
Study type	Interventional
Source	Umeå University
Contact
Status	Completed
Phase	N/A
Start date	January 2011
Completion date	April 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03597646` - The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure	N/A
Terminated	`NCT04065997` - Apogee International
Withdrawn	`NCT03675113` - Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure	N/A
Completed	`NCT02916160` - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study	Phase 4
Completed	`NCT03126656` - Effects of Testosterone on Myocardial Repolarization	Phase 4
Completed	`NCT02268500` - VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)	Phase 4
Completed	`NCT02247245` - The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.	N/A
Terminated	`NCT01906957` - Cognition and Exercise Training	N/A
Completed	`NCT01919918` - Muscle Afferent Feedback Effects in Patients With Heart Failure	Phase 1
Not yet recruiting	`NCT01669395` - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial	N/A
Completed	`NCT00984529` - Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia	N/A
Recruiting	`NCT00863421` - Sleep Disordered Breathing in Patients With Chronic Heart Failure	N/A
Completed	`NCT02840565` - Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453	Phase 1
Completed	`NCT02441218` - Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study	Phase 3
Completed	`NCT00149409` - Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure	Phase 2/Phase 3
Terminated	`NCT05532046` - A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)	Phase 1
Recruiting	`NCT04984928` - Readmission Risk of Patients With Heart Failure.
Completed	`NCT02814097` - A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction	Phase 2
Active, not recruiting	`NCT05560737` - ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Recruiting	`NCT03286127` - Palliative Outcome Evaluation Muenster I

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms