Heart FailureChannel-HFNCT03401151
CHANges iN skEletal muscLe in Heart Failure
An observational study of Heart Failure, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Heart Failure
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe heart failure
Who may be able to join
- Signed informed consent
- 60-80 years old upon inclusion
- Chronic heart failure ≥ 45 days.
- Left ventricular ejection fraction ≤ 35%.
- NYHA III-IV
- 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.
Who cannot join
- Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 "crash and burn"
- On-going mechanical circulatory support.
- Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung disease.
- Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance
- 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.
- Participation in studies that resulted in departure from normal treatment routine or invasive investigations within <6 months back in time.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Stockholm County, 144 86
Michael Melin, MD, #46723888636, michael.melin@sll.se
Eric Rullman, MD, PhD, #46739708096, eric.rullman@ki.se
About this study
Official title: Changes in Skeletal Muscle Over Time in Severe Heart Failure
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.
The 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.
Read the detailed description
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.
The 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.
The study will be conducted in Sweden at Karolinska University Hospital, Huddinge.
- Conditions
- Heart Failure
- Keywords
- Heart failure, Skeletal muscle, Exercise capacity, Lung function, Gene expression
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic signature of muscle, messenger RNA (mRNA) gene expression
Metabolomics profile using nuclear magnetic resonance (NMR)
Measured: Change from baseline metabolic signature at 24 months
Metabolic signature of muscle, messenger RNA (mRNA) gene
Metabolomics profile using liquid chromatography-high-resolution mass spectrometry (LC-HRMS)
Measured: Change from baseline metabolic signature at 24 months
Secondary outcomes (5)
Metabolic signature of blood, mRNA gene expression
Metabolomics profile using NMR
Measured: Change from baseline metabolic signature at 24 months
Metabolic signature of blood, mRNA gene expression
Metabolomics profile using LC-HRMS
Measured: Change from baseline metabolic signature at 24 months
Metabolic signature of satellite cells, mRNA gene expression
Metabolomics profile using NMR
Measured: Change from baseline metabolic signature at 24 months
Metabolic signature of satellite cells, mRNA gene expression
Metabolomics profile using LC-HRMS
Measured: Change from baseline metabolic signature at 24 months
Expression levels of targeted genes using transcriptomics
Choice of genes based on results obtained by metabolomics approaches
Measured: Change from baseline metabolic signature at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Feb 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Thomas Gustafsson Assoc Prof, Karolinska Institutet
- Investigators
- Matti Sällberg, professor, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401151
- Sponsor's protocol ID
- Channel-HF KI
- Acronym
- Channel-HF
- Status last verified
- Oct 2020
- First submitted
- 20 Nov 2017
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Skeletal Muscle Over Time in Severe Heart Failure
- ClinicalTrials.gov ID
- NCT03401151
- Acronym / sponsor ID
- Channel-HF / Channel-HF KI
- Conditions
- Heart Failure
- Keywords
- Heart failure, Skeletal muscle, Exercise capacity, Lung function, Gene expression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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.
Detailed description
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.
The 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.
The study will be conducted in Sweden at Karolinska University Hospital, Huddinge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe heart failure
Key inclusion criteria (6 listed)
- Signed informed consent
- 60-80 years old upon inclusion
- Chronic heart failure ≥ 45 days.
- Left ventricular ejection fraction ≤ 35%.
- NYHA III-IV
Key exclusion criteria (6 listed)
- Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 "crash and burn"
- On-going mechanical circulatory support.
- Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung disease.
- Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic signature of muscle, messenger RNA (mRNA) gene expression
Time frame: Change from baseline metabolic signature at 24 months
Metabolomics profile using nuclear magnetic resonance (NMR)
Metabolic signature of muscle, messenger RNA (mRNA) gene
Time frame: Change from baseline metabolic signature at 24 months
Metabolomics profile using liquid chromatography-high-resolution mass spectrometry (LC-HRMS)
5 secondary outcomes
Metabolic signature of blood, mRNA gene expression
Time frame: Change from baseline metabolic signature at 24 months
Metabolic signature of blood, mRNA gene expression
Time frame: Change from baseline metabolic signature at 24 months
Metabolic signature of satellite cells, mRNA gene expression
Time frame: Change from baseline metabolic signature at 24 months
Metabolic signature of satellite cells, mRNA gene expression
Time frame: Change from baseline metabolic signature at 24 months
Expression levels of targeted genes using transcriptomics
Time frame: Change from baseline metabolic signature at 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
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A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
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Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matti Sällberg, professor study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Gustafsson, MD, PhD (+46707415124, thomas.gustafsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic signature of muscle, messenger RNA (mRNA) gene expression (time frame: Change from baseline metabolic signature at 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.