Heart Failure With Preserved Ejection FractionNCT04175080
Clinical Significance and Diagnosis of Sarcopenia in Cardiac Patients
An observational study of Heart Failure With Preserved Ejection Fraction and Hypertension, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Obesity sarcopenia, characterized by the coexistence of excess fat and muscle mass reduction, may contribute to the pathophysiology of exercise intolerance in patients with heart failure with preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Hypertension, Sarcopenic Obesity
- How many people
- 190 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2017to Nov 2019
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults in the age 35-70. Patients will be recruited from the patients of Cardiology Outpatient Clinic and Nephrology, Hypertension and Family Medicine Clinic of the University Clinical Hospital WAM - Central Veterans Hospital in Łódź
Who may be able to join
- control group: healthy volunteers
- study groups: patients with HFpEF. Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group.
Who cannot join
- coronary artery disease
- unstable hypertension
- heart failure class IV NYHA
- condition after percutaneous or surgical revascularization
- pulmonary hypertension in echocardiography
- obstructive or restrictive lung diseases
Show all 16Show fewer
- congenital heart disease
- arrhythmias (including atrial fibrillation)
- pacemaker or implantable cardioverter defibrillator
- hyperthyroidism or hypothyroidism
- pregnancy or lactation
- hemodynamically significant acquired heart defects
- cardiomyopathies
- GFR <60 ml/min/1.73 m2
- other medical conditions such as: cancer, significant anemia, diabetes, alcohol and drug abuse, chronic inflammatory diseases and other
- the patient's inability to cooperate and / or give informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Significance and Diagnosis of Sarcopenia in Patients With Heart Failure With Preserved Ejection Fraction
Obesity sarcopenia, characterized by the coexistence of excess fat and muscle mass reduction, may contribute to the pathophysiology of exercise intolerance in patients with heart failure with preserved ejection fraction (HFpEF). The project will examine the impact of selected circulating miRNAs on processes that may form the pathophysiological basis for HFpEF development and obesity sarcopenia in correlation with biochemical markers, echocardiographic assessment and non-invasive assessment of hemodynamic parameters. In addition, the impact of LDL and HDL on these diseases will be assessed. Determinations of selected adipokines and asymmetric dimethylarginine will also be carried out and their effects on the cardiovascular system will be assessed.
- Medical subject headings
- Hypertension
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 |
|---|---|---|
| Control | Not described | |
| HFpEF group | Not described | |
| Hypertensive group | Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of biochemical parameters
Measured: through study completion, an average of 1 year
Left ventricular systolic and diastolic function
Measured: through study completion, an average of 1 year
Arterial stiffness
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Mar 2017
- Primary completion31 Aug 2019
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agata Bielecka-Dabrowa, MD, PhD, Department of Hypertension, Medical University of Lodz
- Investigators
- Agata Bielecka-Dąbrowa, MD, PhD, Principal investigator, Department of Hypertension Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175080
- Sponsor's protocol ID
- RNN/80/17/KE
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paduszynska A, Sakowicz A, Banach M, Maciejewski M, Dabrowa M, Bielecka-Dabrowa A. Cardioprotective properties of leptin in patients with excessive body mass. Ir J Med Sci. 2020 Nov;189(4):1259-1265. doi: 10.1007/s11845-020-02211-9. Epub 2020 Mar 20.
PubMed 32198598
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance and Diagnosis of Sarcopenia in Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04175080
- Acronym / sponsor ID
- RNN/80/17/KE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 22 Nov 2019 (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.
Obesity sarcopenia, characterized by the coexistence of excess fat and muscle mass reduction, may contribute to the pathophysiology of exercise intolerance in patients with heart failure with preserved ejection fraction (HFpEF). The project will examine the impact of selected circulating miRNAs on processes that may form the pathophysiological basis for HFpEF development and obesity sarcopenia in correlation with biochemical markers, echocardiographic assessment and non-invasive assessment of hemodynamic parameters. In addition, the impact of LDL and HDL on these diseases will be assessed. Determinations of selected adipokines and asymmetric dimethylarginine will also be carried out and their effects on the cardiovascular system will be assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| HFpEF group | – | – |
| Hypertensive group | – | –Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults in the age 35-70. Patients will be recruited from the patients of Cardiology Outpatient Clinic and Nephrology, Hypertension and Family Medicine Clinic of the University Clinical Hospital WAM - Central Veterans Hospital in Łódź
Key inclusion criteria (2 listed)
- control group: healthy volunteers
- study groups: patients with HFpEF. Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group.
Key exclusion criteria (16 listed)
- coronary artery disease
- unstable hypertension
- heart failure class IV NYHA
- condition after percutaneous or surgical revascularization
- pulmonary hypertension in echocardiography
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
The level of biochemical parameters
Time frame: through study completion, an average of 1 year
Left ventricular systolic and diastolic function
Time frame: through study completion, an average of 1 year
Arterial stiffness
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 32198598Paduszynska A, Sakowicz A, Banach M, Maciejewski M, Dabrowa M, Bielecka-Dabrowa A. Cardioprotective properties of leptin in patients with excessive body mass. Ir J Med Sci. 2020 Nov;189(4):1259-1265. doi: 10.1007/s11845-020-02211-9. Epub 2020 Mar 20.
- Individual participant dataSharing planned: Undecided
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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.
Agata Bielecka-Dąbrowa, MD, PhD principal investigator
Department of Hypertension Medical University of Lodz
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 With Preserved Ejection Fraction and Hypertension, run by Medical University of Lodz at 1 site in Poland.
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 2 inclusion and 16 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 22 Nov 2019. 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 Poland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of biochemical parameters (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04175080, which also lists 1 linked publication.
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 22 Nov 2019.