Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT03401151
Status:
RECRUITING
Last Update Posted:
2020-10-06
First Post:
2017-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CHANges iN skEletal muscLe in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Blood samples, muscle biopsies\n\nInitial examination and sampling:\n\nA) Blood sampling B) Ecocardiographic examination, C) Maximal working test including oxygen uptake D) Measurement of arm and leg strength using so-called Biodex E) Pulse, blood pressure and cardiac output volume measurement F) Measurement of muscle mass using CT G) Muscle biopsy in local anesthesia taken from one leg's vastus lateralis H) Daily physical activity measured with an accelerometer (pedometer) I) Measurement of lung function using standard spirometry J) Cardiac examination with MR in non-pacemaker subjects\n\n24 months after the first sampling, the persons will be asked to re-examine the same examination procedures."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-04', 'studyFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic signature of muscle, messenger RNA (mRNA) gene expression', 'timeFrame': 'Change from baseline metabolic signature at 24 months', 'description': 'Metabolomics profile using nuclear magnetic resonance (NMR)'}, {'measure': 'Metabolic signature of muscle, messenger RNA (mRNA) gene', 'timeFrame': 'Change from baseline metabolic signature at 24 months', 'description': 'Metabolomics profile using liquid chromatography-high-resolution mass spectrometry (LC-HRMS)'}], 'secondaryOutcomes': [{'measure': 'Metabolic signature of blood, mRNA gene expression', 'timeFrame': 'Change from baseline metabolic signature at 24 months', 'description': 'Metabolomics profile using NMR'}, {'measure': 'Metabolic signature of blood, mRNA gene expression', 'timeFrame': 'Change from baseline metabolic signature at 24 months', 'description': 'Metabolomics profile using LC-HRMS'}, {'measure': 'Metabolic signature of satellite cells, mRNA gene expression', 'timeFrame': 'Change from baseline metabolic signature at 24 months', 'description': 'Metabolomics profile using NMR'}, {'measure': 'Metabolic signature of satellite cells, mRNA gene expression', 'timeFrame': 'Change from baseline metabolic signature at 24 months', 'description': 'Metabolomics profile using LC-HRMS'}, {'measure': 'Expression levels of targeted genes using transcriptomics', 'timeFrame': 'Change from baseline metabolic signature at 24 months', 'description': 'Choice of genes based on results obtained by metabolomics approaches'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Skeletal muscle', 'Exercise capacity', 'Lung function', 'Gene expression'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The mechanisms behind heart failure are largely unknown. Despite an increasing arsenal of pharmacological therapies, cardiovascular disease is still the most common cause of death in the western world, which demonstrates a pronounced need for more patient-related mechanistic research. Cachexia and limited exercise capacity are the symptoms that best match prediction of heart failure, both of which are symptoms involving a dysfunctional skeletal muscle. An increased understanding of the mechanisms and signaling pathways connects the failure heart with skeletal muscle dysfunction is likely to lead both to discoveries of prognostic factors and possible therapeutic options.\n\nThe study is a prospective, non-blinded, study. The study will consist of the assignment of patients with heart failure, New York Heart Association (NYHA) III-IV, 60-80 years old. One hundred (100) patients will be enrolled in this study.', 'detailedDescription': "The primary objective is to investigate how changes in the skeletal muscle coincide with changes in physical performance, cardiac function, and prognosis in patients with heart failure, and changes over time. Therefore, the investigators will investigate patients with severe heart failure at 'baseline' and on a second follow-up occasion after 12-16 months.\n\nThe secondary and tertiary objective is to investigate how changes in the metabolic signature of blood and satellite cells coincide with changes in physical performance, cardiac function, and prognosis in patients with heart failure, and changes over time. Patient recruitment is expected to occur over 36 months.\n\nThe study will be conducted in Sweden at Karolinska University Hospital, Huddinge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe heart failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Signed informed consent\n* 60-80 years old upon inclusion\n* Chronic heart failure ≥ 45 days.\n* Left ventricular ejection fraction ≤ 35%.\n* NYHA III-IV\n* Receiving medical management with optimal doses of betablockers, acetylcholinesterase (ACE)-inhibitors or angiotensin II receptor blockers (ARB), and mineral receptor antagonists (MRA) for at least 30 days if tolerated.\n\nExclusion criteria:\n\n* Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 "crash and burn"\n* On-going mechanical circulatory support.\n* Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung disease.\n* Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance\n* Condition, other than heart failure, requiring end-of-life care within \\<6 months in time or where the risk of death within \\<2 years is considered to be imminent.\n* Participation in studies that resulted in departure from normal treatment routine or invasive investigations within \\<6 months back in time.'}, 'identificationModule': {'nctId': 'NCT03401151', 'acronym': 'Channel-HF', 'briefTitle': 'CHANges iN skEletal muscLe in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Changes in Skeletal Muscle Over Time in Severe Heart Failure', 'orgStudyIdInfo': {'id': 'Channel-HF KI'}}, 'contactsLocationsModule': {'locations': [{'zip': '144 86', 'city': 'Stockholm', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Michael Melin, MD', 'role': 'CONTACT', 'email': 'michael.melin@sll.se', 'phone': '#46723888636'}, {'name': 'Eric Rullman, MD, PhD', 'role': 'CONTACT', 'email': 'eric.rullman@ki.se', 'phone': '#46739708096'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Thomas Gustafsson, MD, PhD', 'role': 'CONTACT', 'email': 'thomas.gustafsson@ki.se', 'phone': '+46707415124'}, {'name': 'Eric Rullman, MD, PhD', 'role': 'CONTACT', 'email': 'eric.rullman@ki.se', 'phone': '+46739708096'}], 'overallOfficials': [{'name': 'Matti Sällberg, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Thomas Gustafsson Assoc Prof', 'investigatorAffiliation': 'Karolinska Institutet'}}}}