Last updated: April 16, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Completed
Phase
N/A
Condition
Heart Failure
Congestive Heart Failure
Chest Pain
Treatment
SanaCoach Heart failure
Clinical Study ID
NCT04699253
NL75892.068.20
NWE702
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients must meet ALL of the following criteria in order to be eligible for this study.
- Adults (≥18 years) that own a device where SanaCoach heart failure can be used on
- Diagnosis of chronic heart failure according to ESC 2016 guidelines (HFrEF = LVEF <40%, HFmrEF = LVEF 40-49%, HFpEF = LVEF ≥ 50%), based on echocardiographic or MRIfindings within the last year or considered stable before.
- Ability and willingness to give written informed consent and to comply with therequirements of the study
Exclusion
Exclusion Criteria: Patients meeting any of the following criteria are NOT eligible for this study
- Patients without access to a device where SanaCoach heart failure can be used on
- Uncontrolled or serious disease, or any medical or surgical condition, that may eitherinterfere with participation in the clinical study, and/or put the subject atsignificant risk (according to investigator's [or delegate] judgment) if he/sheparticipates in the clinical study.
- Patients that have been hospitalised for heart failure within the last 30 days.
- An underlying known disease, or surgical, physical, or medical condition that, in theopinion of the investigator (or delegate) might interfere with interpretation of theclinical study results.
- Treatment with other investigational products or devices within 30 days or fivehalf-lives of the screening visit, whichever is longer.
- Planned use of other investigational products or devices during the course of thestudy.
- Any condition that according to the investigator could interfere with the conduct ofthe study, such as but not limited to:
- a. Subjects who are unable to communicate or to cooperate with the investigator.
- b. Unable to understand the protocol requirements, instructions and study-relatedrestrictions, the nature, scope, and possible consequences of the study.
- c. Unlikely to comply with the protocol requirements, instructions, and study-relatedrestrictions (eg, uncooperative attitude, inability to return for follow-up visits,and improbability of completing the study).
- d. Have any medical or surgical condition, which in the opinion of the investigatorwould put the subject at increased risk from participating in the study
- e. Persons directly involved in the conduct of the study.
Study Design
Total Participants: 542
Treatment Group(s): 1
Primary Treatment: SanaCoach Heart failure
Phase:
Study Start date:
July 01, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
University Hospital Aachen
Aachen,
GermanySite Not Available
St. Michael's Hospital Dublin
Dublin,
IrelandSite Not Available
Maastricht UMC+
Maastricht,
NetherlandsSite Not Available
Royal Victoria Hospital Belfast
Belfast,
United KingdomSite Not Available
University of Suffolk
Ipswich,
United KingdomSite Not Available
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