Impact of a Psychological Biofeedback-Relaxation Intervention on Clinical, Physical and Psychological Outcomes in Patients With Heart Failure
Completed · Phase 2 · Has a placebo group
Conditions studied: Heart Failure
In brief
The purpose of this study is to determine the effect of biofeedback-relaxation combined with cognitive behavioral therapy on clinical, physical and psychological outcomes in patients with heart failure.
Key facts
- Study ID
- NCT00255931
- Run by
- University of Kentucky
- People needed
- 380
- Starts
- 2004-07-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2012-06-05
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- confirmed diagnosis of chronic advanced HF. Other sample selection criteria include: 1) on stable doses of HF medication for at least one month; and 2) not referred for heart transplantation.
You may not qualify if…
- Patients will be excluded if they have: 1) valvular heart disease (as a primary cause of their HF; can have it if the primary cause is ischemic, hypertensive or idiopathic), peripartum heart failure, myocarditis; 2) history of cerebral vascular accident (CVA) within previous 3 months or major stroke sequelae; 3) history of major extremity vascular problems; 4) recent (within 3 months) myocardial infarction (MI); 5) coexisting terminal illness; 6) systolic blood pressure less than 80 mmHg; or 7) previous experience with biofeedback, relaxation .
Where it is running
- University of Kentucky — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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