Heart Failure With Preserved Ejection Fraction Clinical Trial
— ARTSPREDICTIONOfficial title:
Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
NCT number | NCT06208007 |
Other study ID # | 9/12/23 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 23, 2024 |
Est. completion date | January 2028 |
Verified date | May 2024 |
Source | University Medical Center Goettingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | January 2028 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: One or more of the following criteria: - Age > 60 years - Arterial hypertension (RR systolic = 140 mmHg or diastolic = 90 mmHg or = 2 antihypertensive drugs) - Diabetes mellitus Type I or II - Atrial fibrillation - Chronic kidney disease (GFR < 60 ml/min/1,73 m2 or urine albumin = 30mg/24h or ACR = 30 mg/g) - BMI = 30 kg/m2 - NYHA = II - E/e' > 8 Exclusion Criteria: - Left ventricular ejection fraction < 50 % - Significant valve disease (Grade III or higher) - History of interventional or surgical valve repair - Regional wall motion abnormalities - Respiratory diseases as a known cause for dyspnea - Atrial flutter or fibrillation during examination - Hypertrophic/restrictive/arrhythmogenic/dilatative cardiomyopathies including cardiac amyloidosis or sarcoidosis and toxic cardiomyopathy - History of heart transplantation |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsmedizin Göttingen | Göttingen | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Goettingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HFA-PEFF-Score | Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; = 5 points: HFpEF [min. 0 points, max. 6 points] | 24 months | |
Primary | Development of HFpEF | Defined as = 5 points in HFA-PEFF-Score Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; = 5 points: HFpEF [min. 0 points, max. 6 points] | 24 months | |
Primary | Composite endpoint cardiovascular events | Cardiovascular hospitalisation or death | 24 months | |
Secondary | Change of individual parameters included in the HFA-PEFF-Score | Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; = 5 points: HFpEF [min. 0 points, max. 6 points] | 24 months | |
Secondary | Change of NT-proBNP | 24 months | ||
Secondary | Change of NYHA-class | 24 months | ||
Secondary | Development or aggravation of albuminuria | 24 months | ||
Secondary | Change of blood-creatinine | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05839730 -
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT05095688 -
Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF
|
||
Recruiting |
NCT06379152 -
Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
|
||
Recruiting |
NCT05676684 -
Dapagliflozin, Spironolactone or Both for HFpEF
|
Phase 2/Phase 3 | |
Recruiting |
NCT04153136 -
Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)
|
Phase 2 | |
Recruiting |
NCT06114498 -
Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
|
||
Recruiting |
NCT05715697 -
Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT04745013 -
PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart
|
N/A | |
Completed |
NCT05586828 -
A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
|
||
Completed |
NCT05126836 -
Cilostazol for HFpEF
|
Phase 2 | |
Recruiting |
NCT04594499 -
The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients
|
||
Active, not recruiting |
NCT05204238 -
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
|
||
Completed |
NCT04535726 -
The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity
|
||
Recruiting |
NCT03550235 -
Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
|
||
Completed |
NCT04633460 -
Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
|
Phase 2 | |
Completed |
NCT06228807 -
Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF
|
||
Active, not recruiting |
NCT05284617 -
Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
|
Phase 2 | |
Recruiting |
NCT05562063 -
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
|
Phase 4 | |
Recruiting |
NCT06027307 -
Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation
|
Phase 3 | |
Withdrawn |
NCT05322616 -
Single-Ascending Dose Study of JK07 in Subjects With HFpEF
|
Phase 1 |