Heart Failure, Congestive Clinical Trial
— TEHAF2Official title:
Telemonitoring in Patients With Heart Failure
The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.
Status | Completed |
Enrollment | 382 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients > 18 years - Patients with heart failure NYHA classification II-III-IV - Patient experienced a period of fluid retention - Patient is treated by a cardiologist - Patient is followed-up by a heart failure nurse - Adequate knowledge of the Dutch language - Patient has an active telephone connection, preferably analogue - Patient is mental competent - Patient has the disposal of a balance Exclusion Criteria: - Patients suffering from COPD, Gold classification 3 or 4 - Patient is a dialysis patient - Patient has a visual restriction to read the dialogues on the Health Buddy - Patient is hard of hearing or deaf - Patient suffers from a lethal sickness with a prognosis < 1 year - Patient participates in another trial - Patient needs a hospital admission on short time, i.e., < 3 months - Patient used the Health Buddy in an earlier stage - Patient is an illiterate person. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Netherlands | Atrium Medische Centrum | Heerlen | Limburg |
Netherlands | Maastricht University Hospital | Maastricht | Limburg |
Netherlands | Orbis Medische en Zorgconcern | Sittard | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Maastricht University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To what extent does the use of Health Buddy result in a decrease in hospital admissions? | one year | No | |
Primary | To what extent is Health Buddy® more cost-effective than usual care? | one year | No | |
Primary | To what extent will the amount of planned contacts decrease without an increase of unplanned contacts? | one year | No | |
Secondary | What is the effect of Health Buddy® in patients with heart failure in regard to drug consumption and therapy compliance and level of knowledge, and quality of life? | one year | No | |
Secondary | To what extent is it - based on patients' characteristics - possible to identify patient with benefits? | one year | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01357850 -
A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure
|
Phase 2 | |
Recruiting |
NCT00532688 -
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
|
Phase 2/Phase 3 | |
Terminated |
NCT00383630 -
Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure
|
Phase 2 | |
Completed |
NCT00531661 -
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
|
N/A | |
Completed |
NCT00159614 -
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
|
Phase 2 | |
Terminated |
NCT00125437 -
Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
|
N/A | |
Completed |
NCT00241761 -
Epidemiology of Depression and Heart Failure in Aging
|
N/A | |
Completed |
NCT00149435 -
Cardiovascular Health Study (CHS) Events Follow-up Study
|
||
Completed |
NCT00094263 -
Long-Term Predictors of Morbidity in Older Age
|
N/A | |
Completed |
NCT00202579 -
Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure
|
Phase 2 | |
Terminated |
NCT00357591 -
Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation
|
N/A | |
Completed |
NCT00048425 -
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
|
Phase 3 | |
Completed |
NCT00530426 -
Heart Failure Registry
|
Phase 4 | |
Completed |
NCT00023556 -
Genetic Architecture of Heart Disease in Rural Brazil
|
N/A | |
Terminated |
NCT00190359 -
Growth Hormone and Heart Failure
|
N/A | |
Completed |
NCT00004562 -
Occluded Artery Trial (OAT)
|
Phase 3 | |
Completed |
NCT00005265 -
Natural History of Coronary Heart Disease
|
N/A | |
Completed |
NCT02772068 -
Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a
|
Early Phase 1 | |
Completed |
NCT02925546 -
A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets
|
Phase 1 | |
Completed |
NCT01074307 -
A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea
|
Phase 4 |