Heart Failure With Normal Ejection Fraction Clinical Trial
Official title:
Cross-sectional Observational Single-center Study to Evaluate Renal Hemodynamics in Patients With Heart Failure and Preserved Ejection Fraction
Verified date | July 2019 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Impaired renal function and heart failure with preserved ejection fraction (HFpEF) are two
often co-existing medical conditions and are known to be associated with adverse
cardiovascular outcome and increased mortality. The relationship between HFpEF and renal
impairment is bidirectional. On the one hand, renal dysfunction has been shown to be an
independent risk factor for the development of HFpEF. On the other hand, an increase in
central venous pressure leading to renal dysfunction by a reduction of renal blood flow (RBF)
and perfusion pressure (RPP) as well as activation of the renin-angiotensin-aldosterone
system (RAAS) in patients with HFpEF has been previously described.
In the literature, several studies aimed to investigate the association between renal (dys-)
function and HFpEF. In all these studies, renal function was assessed by determination of
standard kidney function parameters such as serum creatinine, eGFR and urinary albumin to
creatinine ratio (UACR). Constant infusion input clearance technique however offers a more
detailed evaluation of renal function and hemodynamics. To the best of knowledge, renal
hemodynamics in patients with HFpEF have not yet been investigated by clearance technique.
Therefore, the aim of the present study is to evaluate renal function and hemodynamics by
means of constant infusion input clearance technique with sodium p-aminohippuric acid (PAH)
and Iohexol in 40 patients with HFpEF. The constant infusion input clearance technique offers
an exact evaluation of renal function by measuring (not estimating) glomerular filtration
rate and renal hemodynamic parameters such as renal plasma flow (RPF), filtration fraction
(FF) and intraglomerular pressure (IGP). These results will be compared to 140 subjects
without HFpEF that have participated in various studies and have been analyzed with the same
constant infusion input clearance technique performed in the Clinical Research Center of the
University Hospital Erlangen-Nuremberg. Additionally, flow mediated vasodilation (FMD), pulse
wave velocity and parameters of retinal vascular remodeling by means of scanning laser
Doppler flowmetry (SLDF) will be assessed in patients with HFpEF thereby allowing to examine
the relationship between vascular remodeling in the systemic and renal circulation.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients in good and stable health condition - Informed consent has to be given in written form - HFpEF in stable conditions according to 2016 ESC guidelines definition14 - LVEF = 50% - symptoms and/or signs of CHF - NT-proBNP > 125 pg/ml - At least one additional criterion: relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement and/or diastolic dysfunction Exclusion Criteria: - Uncontrolled diabetes (fasting plasma glucose = 240 mg/dl, HbA1c = 10%) - Uncontrolled arterial hypertension (= 180/110 mmHg) - Any history of stroke, transient ischemic attack, instable angina pectoris or myocardial infarction within the last 6 months prior to study inclusion - Significant valvular heart disease - Known hypertrophic obstructive cardiomyopathy or known pericardial constriction - Atrial fibrillation with a resting heart rate > 90 bpm - Heart transplant recipient - Sickle cell anemia - Pheochromocytoma - Myasthenia gravis - Subclinical or clinical hyperthyroidism - Allergic reaction to iodine - Medication with amiodarone - Estimated glomerular filtration rate < 30 ml/min/1.73m² - Significant laboratory abnormalities such as Serum Glutamate-Oxaloacetate-Transaminase (SGOT) or Serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 times above the upper limit of normal range - Patients in unstable conditions due to any kind of serious disease, that infers with the conduction of the trial - History of epilepsia and history of seizures - Patients suffering from cataract or glaucoma - Diabetic retinopathy - Drug or alcohol abuse - Pregnant and breast-feeding patients - Body mass index > 40 kg/m² - Participation in another clinical study within 30 days prior to visit 1 - Individuals at risk for poor protocol adherence - Subjects who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V |
Country | Name | City | State |
---|---|---|---|
Germany | Clinical Research Center Erlangen, Department of Nephrology and Hypertension, University Hospital Erlangen | Erlangen | |
Germany | Clinical Research Center Nuremberg, Department of Nephrology, University Hospital Erlangen | Nuremberg |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal plasma flow | Volume of blood plasma delivered to the kidneys per unit time (ml/min) | One week after study inclusion | |
Secondary | Flow mediated vasodilation | Measured by UNEX EF in percent | One week after study inclusion | |
Secondary | Wall to lumen ratio of retinal arterioles | ratio of vascular wall thickness to luminal diameter | One week after study inclusion | |
Secondary | Retinal capillary flow | by SLDF measurement in AU | One week after study inclusion | |
Secondary | Office and 24-hour systolic, diastolic and mean ambulatory blood pressure | in mmHg | One week after study inclusion | |
Secondary | Central systolic pressure | measured by SphygmoCor in mmHg | One week after study inclusion | |
Secondary | Pulse pressure | difference between systolic and diastolic blood pressure in mmHg | One week after study inclusion | |
Secondary | Pulse wave velocity | velocity at which the blood pressure pulse propagates through the circulatory System measured by SphygmoCor in m/s | One week after study inclusion | |
Secondary | Glomerular filtration rate | Flow rate of filtered fluid through the kidney in ml/min/1.73m^2 | One week after study inclusion | |
Secondary | Filtration fraction | Ratio of glomerular filtration rate to renal plasma flow in percent | One week after study inclusion | |
Secondary | Renal vascular resistance | Calculated by the Gomez formula in dyn x sec x cm^-5 | One week after study inclusion | |
Secondary | Intraglomerular pressure | in mmHg | One week after study inclusion |
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