NL-OMON46859
Completed
Not Applicable
eural Cardiac Therapy for Heart Failure Study - NECTAR-HF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cardiac remodeling
- Sponsor
- Boston Scientific
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Age 18 or above, or of legal age to give informed consent specific to national laws
- •\* Willing and capable of providing informed consent
- •\* Capable of participating in all testing associated with this clinical investigation
- •\* Symptomatic heart failure NYHA class II or III
- •\* Left ventricular (LV) ejection fraction \<\= 35% documented in patient file within the past 6 months
- •\* Left ventricular end diastolic diameter (LVEDD) of 5\.5 cm or greater documented in patient file within the past 6 months
- •\* Prescribed to optimal pharmacologic therapy according to current local or international guidelines for treatment of acute and chronic heart failure at the time of enrollment, unless contra\-indicated or not\-tolerated, and on a stable dose (e.g., recommended no greater than a 100% increase or 50% decrease in dosage) for at least 30 days prior to enrollment
Exclusion Criteria
- •\* Patients with Cardiac Resynchronization Therapy for less than one year prior to enrollment
- •\* Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment
- •\* Patients unable to tolerate anesthesia required for implant
- •\* Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 3 months (90 days) before enrollment
- •\* Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
- •\* Patients with persistent or permanent atrial fibrillation (AF) (according to the current local or international guidelines for the management of patients with AF at the time of enrollment) within 90 days prior to enrollment
- •\* Pacemaker indicated patients
- •\* Patients whose heart failure is due to congenital heart disease
- •\* Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi\-PAP, APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment
- •\* Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
Clinical study on intervention of heart failure patients after myocardial infarction with Wuqinxi based on the theory of ''supporting yang''Postinfarction heart failureITMCTR2022000105Guang'anmen Hospital, Chinese Academy of traditional Chinese Medicine
Completed
Not Applicable
Pilot study for the treatment of heart failure with PycnogenolHeart failureCirculatory SystemISRCTN22412590Kyoto University (Japan)30
Completed
Not Applicable
Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zincheart failureJPRN-UMIN000020203Tokorozawa Heart Center, Medical Corporation Ouyuukai50
Withdrawn
Not Applicable
eo Randomized Heart Failure Studyheartfailuredecompensatio cordis10019280NL-OMON38346CVRx Inc20
Not yet recruiting
Phase 4
ovel Interventions in Heart Failure with Preserved Ejection Fraction using TadalafilHeart Failure with Preserved Ejection FractionCardiovascular - Other cardiovascular diseasesACTRN12612000684820South Australian Health and Medical Reseasrch Institute20