Understanding how heart failure affects lung blood vessels
Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure
This study is trying to understand how heart failure affects the blood vessels in the lungs to find new ways to help people with these problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague) |
| Trial ID | NCT06331208 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the mechanisms behind pulmonary vascular dysfunction in patients with heart failure, particularly focusing on the metabolic factors that contribute to this condition. By utilizing untargeted metabolomics and advanced imaging techniques, the study aims to identify novel biomarkers and pathways associated with pulmonary vascular disease. Participants will undergo right heart catheterization and various non-invasive tests to gather comprehensive data on their heart and lung function. The findings could lead to targeted therapies for patients suffering from heart failure-related pulmonary vascular issues.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with heart failure and reduced left ventricular ejection fraction.
Not a fit: Patients with severe renal insufficiency, acute coronary syndrome, or other types of pulmonary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new diagnostic tools and treatments for patients with heart failure and pulmonary vascular dysfunction.
How similar studies have performed: While the approach of using metabolomics in this context is relatively novel, similar studies have shown promise in identifying biomarkers for other cardiovascular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
A) Inclusion Criteria HF group: * age\>18y * signed informed consent, * left ventricular (LV) ejection fraction \<50% * duration of HF\>6 months, * loop diuretic use, * clinical indication to right heart catheterisation Control group: * Age \>18years * Signed informed consent * Non-HF subjects referred to Institute for Clinical and Experimental Medicine (IKEM) in Prague for an invasive procedure (PFO closure, arrhythmia ablation, for subjects undergoing RHC) or non-invasive diagnostic evaluation (controls without invasive sampling) B) Exclusion Criteria: Heart Failure group: * Patients with hemodynamic instability requiring inotropic support * Severe renal insufficiency (estimated glomerular filtration rate \<0.6 ml/s) * Acute coronary syndrome * High cardiac output (cardiac index \>4 l/m2) * Known pulmonary hypertension of other type than II (type I, III, IV) * Active infection * Respiration insufficiency * Large pleural effusion * Severe intrinsic lung disease (treated chronic obstructive pulmonary disease (COPD) * asthma, known interstitial lung disease) Control group: * Pulmonary hypertension (RV systolic pressure estimate on screening \> 45 mmHg) * History of recent pulmonary embolism \< 1 year * Echocardiographic evidence of reduced function of right or left ventricle * Treated asthma/COPD, known intersticial lung disease * Significant exercise intolerance (NYHA \> II)
Where this trial is running
Prague
- Institute for Clinical and Experimental Medicine - IKEM — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Vojtech Melenovsky — Institute for Clinical and Experimental Medicine
- Study coordinator: Vojtech Melenovsky, MD, PhD
- Email: vome@ikem.cz
- Phone: 420 236055190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.