Actively Recruiting

Age: 18Years +
All Genders
NCT06331208

Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure

Led by Institute for Clinical and Experimental Medicine · Updated on 2024-08-27

230

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Signed informed consent
  • For heart failure group: left ventricular ejection fraction less than 50%
  • For heart failure group: heart failure duration longer than 6 months
  • For heart failure group: use of loop diuretics
  • For heart failure group: clinical indication for right heart catheterization
  • For control group: non-heart failure subjects referred for invasive or non-invasive diagnostic evaluations
Not Eligible

You will not qualify if you...

  • For heart failure group: hemodynamic instability requiring inotropic support
  • Severe renal insufficiency (estimated glomerular filtration rate less than 0.6 ml/s)
  • Acute coronary syndrome
  • High cardiac output (cardiac index greater than 4 l/m2)
  • Known pulmonary hypertension types other than type II
  • Active infection
  • Respiratory insufficiency
  • Large pleural effusion
  • Severe intrinsic lung disease including treated COPD, asthma, or known interstitial lung disease
  • For control group: pulmonary hypertension with right ventricular systolic pressure estimate over 45 mmHg
  • History of recent pulmonary embolism within one year
  • Echocardiographic evidence of reduced right or left ventricular function
  • Treated asthma or COPD, known interstitial lung disease
  • Significant exercise intolerance (NYHA class greater than II)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institute for Clinical and Experimental Medicine - IKEM

Prague, Czechia, 140 21

Actively Recruiting

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Research Team

V

Vojtech Melenovsky, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure | DecenTrialz