NCT06331208Recruiting
Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure
Source: ClinicalTrials.gov · Last updated 27 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Heart failure (HF) patients often develop pulmonary hypertension (PH) that leads to transition into a biventricular HF with poor prognosis. There are two PH components: 1) passive transmission of increased left atrial pressure, 2) heart failure (HF) related pulmonary vascular dysfunction (PVD) with increased vascular resistance. Intriguingly, only some, but not all HF patients develop heart failure-related PVD. The mechanisms and non-invasive detection of HF-PVD are poorly understood and are the focus of the current grant application. Development of PVD is linked to insufficiently characterized metabolic factors that may be mediators of HF-PVD. Untargeted metabolomics is an emerging powerful platform for the discovery of pathways linked to diseases. Its specificity can be further enhanced using transpulmonary gradient sampling. Part A of the project aims to identify novel metabolites associated with the presence of PVD in patients with HF that can serve as biomarkers or targets and will provide biologic insights into PVD. Part C will assess the effects of reverting of metabolic alterations (identified in part A) by a drug/diet on pulmonary vasculature in experimental HF-related PVD. The "gold standard" for the detection of PVD is right heart catheterization, which is invasive and risky. Heart failure-related PVD is therefore often diagnosed late. There is a need for noninvasive tests that may help to detect PVD in early stages and can be done repeatedly. Recent advances in artificial intelligence (AI)-assisted automated quantitative analysis of lung texture from low-dose contrast-free high-resolution CT images allow to quantify lung water content, interstitial changes or vessel volume, and may provide clues for detection of heart failure-related PVD. Such an approach, not tested yet, will be utilized for the detection of HF-PVD (part B). Clinical and functional characteristics of lung circulation (exercise hemodynamics, diffusion capacity, perfusion) will be analyzed in relation to quantitative CT data.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 230 (estimated)
- First submitted
- 23 Feb 2024
- Start date
- 23 Aug 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- NCT number
- NCT06331208
What you commit to
- Study type: Observational
- Planned participants: 230
- From 23 Aug 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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)
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Clinical and Experimental Medicine (IKEM) Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.