Heart FailureNCT02550808
Metabolic Changes in Patients With Chronic Cardiopulmonary Disease
An observational study of Heart Failure and Chronic Obstructive Pulmonary Disease, run by General and Teaching Hospital Celje at 1 site in Slovenia.
Trial summary
This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. The investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease, Malignancy
- How many people
- 400 participants
- Where
- 1 siteSlovenia
- Study dates
- Mar 2012to Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic disease (Heart failure, COPD, malignancy, CKD) and healthy controls
Who may be able to join
- diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis (controls)
Who cannot join
- refuse to participate
Trial locations and contacts
1 site in 1 country.
Mitja Lainscak contact
Slovenia1 site, 1 recruiting
- Recruiting
General Hospital Celje
Celje, SI-3000
Mitja Lainscak, MD, PhD, mitja.lainscak@guest.arnes.si
About this study
Official title: Metabolic and Histological Changes in Skeletal Muscle and Fat Tissue in Patients With Chronic Cardiopulmonary Disease
This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. The investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Neoplasms, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Not described | |
| Chronic obstructive pulmonary disease | Not described | |
| Chronic kidney disease | Not described | |
| Malignancy | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance (HOMA-IR)
HOMA-IR as calculated by formula using insulin and blood glucose
Measured: Baseline
Secondary outcomes (5)
Muscle strength (Handgrip test)
Handgrip test
Measured: Baseline
Change in exercise capacity (6 minute walk test)
Determined by incremental exercise test, 6 minute walk test
Measured: baseline and after 5 weeks
Neurohormonal activation (NT-proBNP concentration)
NT-proBNP concentration
Measured: Baseline
Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm)
histological evaluation: number of apoptotic cells per square mm
Measured: Baseline and after 5 weeks
Change in insulin resistance (HOMA-IR)
HOMA-IR as calculated by formula using insulin and blood glucose
Measured: Baseline and after 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startMar 2012
- Primary completionJul 2016 (estimated)
- Study completionDec 2017 (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.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General and Teaching Hospital Celje
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, General Hospital Murska Sobota, Maastricht University
- Responsible party
- Principal investigator, Mitja Lainscak, General and Teaching Hospital Celje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550808
- Sponsor's protocol ID
- ML-MTB-001
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Histological Changes in Skeletal Muscle and Fat Tissue in Patients With Chronic Cardiopulmonary Disease
- ClinicalTrials.gov ID
- NCT02550808
- Acronym / sponsor ID
- ML-MTB-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- General and Teaching Hospital CeljeUniversity, hospital or other
- Collaborators
- University of Ljubljana, General Hospital Murska Sobota, Maastricht University
- Study start
- Mar 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Sep 2015 (estimated)
- 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.
This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. The investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | – |
| Chronic obstructive pulmonary disease | – | – |
| Chronic kidney disease | – | – |
| Malignancy | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic disease (Heart failure, COPD, malignancy, CKD) and healthy controls
Key inclusion criteria (1 listed)
- diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis (controls)
Key exclusion criteria (1 listed)
- refuse to participate
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
Insulin resistance (HOMA-IR)
Time frame: Baseline
HOMA-IR as calculated by formula using insulin and blood glucose
5 secondary outcomes
Muscle strength (Handgrip test)
Time frame: Baseline
Change in exercise capacity (6 minute walk test)
Time frame: baseline and after 5 weeks
Neurohormonal activation (NT-proBNP concentration)
Time frame: Baseline
Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm)
Time frame: Baseline and after 5 weeks
Change in insulin resistance (HOMA-IR)
Time frame: Baseline and after 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
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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.
Mitja Lainscak contact
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 and Chronic Obstructive Pulmonary Disease, run by General and Teaching Hospital Celje at 1 site in Slovenia.
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 1 inclusion and 1 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 16 Sep 2015. 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 Slovenia. 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 Mitja Lainscak (mitja.lainscak@guest.arnes.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (HOMA-IR) (time frame: Baseline). 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 16 Sep 2015.