Heart Failure, Congestive Clinical Trial
Official title:
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
The SENSE-HF study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid Trends data in predicting Heart Failure related hospitalizations and health care utilizations associated with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines for subject therapy management.
The SENSE-HF study prospectively evaluates the OptiVol feature in the prediction of Heart
Failure related events associated with signs and symptoms of pulmonary congestion and in the
subject HF therapy management.
The OptiVol feature is based on the measurement of daily intrathoracic impedance values,
measurements that can be used to track changes in the subject's thoracic fluid status over
time. An Alert warns the patient whenever a programmable threshold has been reached.
The study is divided into three phases.
The first phase is double-blinded and designed to determine the sensitivity and positive
predictive value of the OptiVol Fluid Trends data for the detection of Heart Failure related
hospitalizations with signs and/or symptoms of pulmonary congestion.
In the second phase of the study, the Alert is turned ON and the positive predictive value of
the first OptiVol Patient Alert for the development of signs and/or symptoms of pulmonary
congestion will be evaluated.
The third phase of the study allows for remote subject therapy management using the OptiVol
Patient Alert. The patient management strategy is then based on the experience gained in the
second study phase Physician actions taken in the occurrence of a Patient Alert will be
summarized.
;
| 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 | |
| Completed |
NCT00241761 -
Epidemiology of Depression and Heart Failure in Aging
|
N/A | |
| Terminated |
NCT00125437 -
Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
|
N/A | |
| Completed |
NCT00149435 -
Cardiovascular Health Study (CHS) Events Follow-up Study
|
||
| Terminated |
NCT00357591 -
Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation
|
N/A | |
| 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 | |
| Completed |
NCT00048425 -
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
|
Phase 3 | |
| Completed |
NCT00023556 -
Genetic Architecture of Heart Disease in Rural Brazil
|
N/A | |
| Completed |
NCT00530426 -
Heart Failure Registry
|
Phase 4 | |
| 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 |