Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis

NCT03585933 | Unknown

• 2 other identifiers: 101409.3.3-LMT-K-712
• Study Type: observational
• Target: 110
• Locations: 2 countries
• Sites: 2

Brief Summary

Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism of the heart. Morphological changes such as increasing muscle fibre thickness, collagen volume, and interstitial fibrosis occur in AS patients. These changes result in left ventricular (LV) diastolic and systolic dysfunction and, consequently, to with AS related symptoms. When symptoms associated with AS appear, patients' prognosis is poor if surgical aortic valve replacement (SAVR) or a trans-catheter aortic valve implantation (TAVI) is not performed. Primary hypothesis of the research: fibrotic changes in the myocardium are related to immediate (in hospital) or long-term complications (MACE and all-cause mortality) in patients with severe AS. The goal of the study is to determine the prognostic implications of focal as well as diffuse myocardial fibrosis in patients with severe aortic valve stenosis.

Conditions

Aortic Stenosis, Calcific

Keywords

Myocardial fibrosis; Severe aortic stenosis; Cardiovascular magnetic resonance; Scintigraphy; SAVR/TAVI

Outcome Measures

Primary Outcomes (1)

• A composite of all-cause mortality and MACE (Acute myocardial infarction, stroke, heart failure requiring hospitalisation)

  2 years

Secondary Outcomes (4)

• Cardiovascular mortality

  2 years

• Short term mortality

  30 days

• Lengh of hospital stay

  30 days

• Time to the event ( deathe of MACE)

  2 years

Interventions

Cardiac magnetic resonance imaging DIAGNOSTIC_TEST

Echocardiography: assessment of aortic stenosis severity, evaluation of LV diastolic and systolic function; CMR: chambers quantification, LGE, T1 mapping; Intraoperative myocardial tissue biopsy for patients undergoing SAVR; DPD scintigraphy: assessment of cardiac transthyretin amyloidosis

Also known as: echocardiography, Intra-operative myocardial biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic stenosis without significant coronary artery disease (CAD), eligible for aortic valve intervention (SAVR or TAVI).

You may qualify if:

• Severe aortic stenosis (aortic valve area \<1.0cm2 or aortic valve area index \<0.6 cm2/m2
• Age ≥18 years.
• Signed informed patient consent form.

You may not qualify if:

• Severe valvular disease other than AS.
• Significant coronary heart disease requiring revascularisation.
• History of myocardial infarction.
• Previous cardiac surgery.
• Severe renal impairment eGFR \<30ml/min/1.73m2.
• Any absolute contraindication to CMR.
• Inherited or acquired cardiomyopathy.
• Other medical conditions that limits life expectancy or precludes SAVR or TAVI.
• Pregnant or nursing women
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
• Patients in permanent atrial fibrillation.
• Significant chronic obstructive pulmonary disease (FEV1 \<70% of predicted value)
• Patient with implanted devices (pacemaker, ICD)

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (2)

Aalborg University Hospital

Aalborg, Denmark

Location

Vilnius University Hospital Santaros clinics

Vilnius, 08416, Lithuania

Location

Related Publications (1)

• Balciunaite G, Palionis D, Zurauskas E, Skorniakov V, Janusauskas V, Zorinas A, Zaremba T, Valeviciene N, Aidietis A, Serpytis P, Rucinskas K, Sogaard P, Glaveckaite S. Prognostic value of myocardial fibrosis in severe aortic stenosis: study protocol for a prospective observational multi-center study (FIB-AS). BMC Cardiovasc Disord. 2020 Jun 8;20(1):275. doi: 10.1186/s12872-020-01552-8.

  PMID: 32513178 DERIVED

Biospecimen

Retention: NONE RETAINED

Serum, myocardial tissue samples obtained intra-operatively

MeSH Terms

Conditions

Aortic Valve, Calcification of; Aortic Valve Stenosis

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Peter Sogaard, Prof.

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peter Sogaard, Clinical Professor

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: May 8, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

DK (1); LI (1)