Clinical trial NCT05055180: Right Ventricular Function and Pulmonary Hypertension in HFpEF
Official title: Afterload Dependence of Right Ventricular Myocardial Remodeling and Intrinsic Right Ventricular Myocardial Function in Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: University Hospital Muenster
First posted: 2021-09-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient general cardiology clinic

Brief summary: In patients with heart failure and preserved ejection fraction (HFpEF) right ventricular (RV) systolic and diastolic dysfunction are prognostically and functionally relevant factors but have mechanistically been neglected so far. In the present study alterations of intrinsic RV (systolic and diastolic) function, as assessed by invasive pressure volume loops, are examined in relation to tissue alterations on myocardial level and to the degree of RV afterload (pulmonary hypertension). Study aim is to gain insights into mechanisms contributing to the development of RV dysfunction and potentially identify new therapeutic targets.


Eligibility criteria: HFpEF

Inclusion Criteria:

* Clinical signs of heart failure
* Preserved Left ventricular (LV) Ejection Fraction (EF \>= 50%)
* Structural Heart Diseases on echocardiogram/ N terminal-pro-brain natriuretic peptide \> 125ng/l
* Elevated LV end-diastolic pressure at rest (\>15mmHg) or during exertion (\>=25mmHg)

No Heart Failure

Inclusion Criteria:

* No signs of heart failure
* Preserved Left ventricular (LV) Ejection Fraction (EF \>= 50%)
* Normal LV end-diastolic pressure at rest (=\<15mmHg) and during exertion (\<25mmHg)

Exclusion Criteria:

* Significant coronary artery stenosis at time of catheterization
* Acute coronary syndrome or cerebral insult within 1 month of examination
* more than moderate valvular diseases
* pregnancy
* contraindication to cardiac magnetic resonance imaging

Primary outcomes:
measure: Right ventricular systolic and diastolic function
timeFrame: Baseline
measure: Biventricular myocardial fibrosis
timeFrame: Baseline
measure: Phosphorylation of structural myocardial proteins
timeFrame: Baseline
Secondary outcomes:
measure: Functional capacity
timeFrame: Baseline
measure: Myocardial fibrosis on cardiac magnetic resonance
timeFrame: Baseline
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig at Leipzig University
state: Saxony
Study officials:
References:
citation: Rommel KP, von Roeder M, Oberueck C, Latuscynski K, Besler C, Blazek S, Stiermaier T, Fengler K, Adams V, Sandri M, Linke A, Schuler G, Thiele H, Lurz P. Load-Independent Systolic and Diastolic Right Ventricular Function in Heart Failure With Preserved Ejection Fraction as Assessed by Resting and Handgrip Exercise Pressure-Volume Loops. Circ Heart Fail. 2018 Feb;11(2):e004121. doi: 10.1161/CIRCHEARTFAILURE.117.004121.
citation: von Roeder M, Kowallick JT, Rommel KP, Blazek S, Besler C, Fengler K, Lotz J, Hasenfuss G, Lucke C, Gutberlet M, Thiele H, Schuster A, Lurz P. Right atrial-right ventricular coupling in heart failure with preserved ejection fraction. Clin Res Cardiol. 2020 Jan;109(1):54-66. doi: 10.1007/s00392-019-01484-0. Epub 2019 May 3.