Other Clinical Trial - Left Ventricular Stiffness vs. Fibrosis

Status Completed

Clinical Trial Summary

StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac MRI is a valid, non-invasive method to assess diastolic function in patients with Heart Failure with preserved ejection fraction.

Clinical Trial Description

Heart Failure with preserved ejection fraction (HFpEF) and diastolic dysfunction is a growing medical challenge. To date almost every second patient with heart failure has a preserved ejection fraction and recent data show that outcomes in these patients are as bad as in those with reduced ejection fraction. In clinical routine the diagnosis of HFpEF is complicated by indirect assessment of diastolic function. Mechanistically the diastolic dysfunction is among others believed to be caused by the development of diffuse myocardial fibrosis with an increase of extracellular matrix. Direct assessment of the intrinsic diastolic function and stiffness of the ventricle can be obtained by pressure-volume-curve tracings through a conductance catheter. Although this offers the benefit of assessing load-dependent and load-independent parameters of diastolic function as well as information on contractility and ventricular-arterial coupling, the use of this technique is limited by its invasiveness in daily care. Newer MRI techniques have made it possible to quantify not only local fibrosis but also diffuse fibrosis (i.e. T1-Mapping) and determine extracellular volumes. Moreover, the role of right ventricular function is in HFpEF is not well defined. Aim of the current study is therefore to evaluate the role of MRI in assessing cardiac fibrosis in the context of impaired LV diastolic function in HFpEF patients, as well as to evaluate the role of systolic and diastolic right ventricular functional impairment in this patient cohort. ;

Study Design

Related Conditions & MeSH terms

Heart Failure
Heart Failure With Normal Ejection Fraction

Clinical Trial Details

NCT number	NCT02459626
Study type	Observational
Source	Heart Center Leipzig - University Hospital
Contact
Status	Completed
Phase
Start date	September 2014
Completion date	December 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03549559` - Imaging Histone Deacetylase in the Heart	N/A
Completed	`NCT02173548` - Interleukin-1 Blockade in HF With Preserved EF	Phase 2
Completed	`NCT03310099` - Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients	N/A
Completed	`NCT02638961` - Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of HFpEF	N/A
Completed	`NCT03871803` - β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR)	Phase 4
Completed	`NCT03672591` - Renal Hemodynamics in Patients With HFpEF
Recruiting	`NCT03620526` - Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction	Phase 4
Active, not recruiting	`NCT03624010` - Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients	Phase 2
Completed	`NCT03541603` - Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF	Phase 2
Completed	`NCT03141567` - LYmphangiogenesis FacTors in Heart Failure States
Completed	`NCT02744339` - Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction	Phase 2
Completed	`NCT03387813` - Hemodynamic-GUIDEd Management of Heart Failure	N/A
Completed	`NCT03186833` - The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.
Completed	`NCT03289481` - Treatment of HFpEF With Nitrate Supplement	Early Phase 1
Terminated	`NCT03195660` - Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study	N/A
Completed	`NCT03226652` - Heart Function in Patients Assessed for Sleep Apnoea
Completed	`NCT03966755` - Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF	N/A
Not yet recruiting	`NCT04282850` - Ablation Versus Medical Management of Atrial Fibrillation in HFpEF	N/A
Recruiting	`NCT03184311` - High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction	N/A
Withdrawn	`NCT03317314` - Cardiopulmonary Interactions in Patients With Heart Failure

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction — STIFFMAP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms