Renal Hemodynamics in Patients With HFpEF

NCT03672591 | Completed

• 1 other identifier: CRC2018HFpEF
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure With Normal Ejection Fraction

Keywords

Heart failure; Renal clearance technique; Preserved ejection fraction

Outcome Measures

Primary Outcomes (1)

• Renal plasma flow

  Volume of blood plasma delivered to the kidneys per unit time (ml/min)

  One week after study inclusion

Secondary Outcomes (11)

• Flow mediated vasodilation

  One week after study inclusion

• Wall to lumen ratio of retinal arterioles

  One week after study inclusion

• Retinal capillary flow

  One week after study inclusion

• Office and 24-hour systolic, diastolic and mean ambulatory blood pressure

  One week after study inclusion

• Central systolic pressure

  One week after study inclusion

Study Arms (2)

HFpEF patients

Patients suffering from heart failure with preserved ejection fraction

Other: Renal clearance examination

Control group

Subjects without HFpEF who participated in different studies during which renal clearance examination has been performed with the constant infusion input clearance technique in our Clinical Research Center (clin. gov. numbers: NCT00627952, NCT01835678, NCT00136188, NCT00905528, NCT00160745)

Other: Renal clearance examination

Interventions

Renal clearance examination OTHER

Evaluation of renal hemodynamic parameters by constant-infusion input clearance technique with p-aminohippuric acid and Iohexol

Also known as: Scanning laser Doppler flowmetry, SphygmoCor, UnexEF

Control group; HFpEF patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HFpEF patients: recruitment from the investigator's outpatient clinics and referring physicians. Control subjects without HFpEF: individuals who already participated in different studies during which renal clearance examination has been performed with the constant infusion input clearance technique in our Clinical Research Center (clin. gov. numbers: NCT00627952, NCT01835678, NCT00136188, NCT00905528, NCT00160745)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled diabetes (fasting plasma glucose ≥ 240 mg/dl, HbA1c ≥ 10%)
• Uncontrolled arterial hypertension (≥ 180/110 mmHg)
• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (2)

Clinical Research Center Erlangen, Department of Nephrology and Hypertension, University Hospital Erlangen

Erlangen, Germany

Location

Clinical Research Center Nuremberg, Department of Nephrology, University Hospital Erlangen

Nuremberg, Germany

Location

Related Publications (1)

• Jung S, Bosch A, Kolwelter J, Striepe K, Kannenkeril D, Schuster T, Ott C, Achenbach S, Schmieder RE. Renal and intraglomerular haemodynamics in chronic heart failure with preserved and reduced ejection fraction. ESC Heart Fail. 2021 Apr;8(2):1562-1570. doi: 10.1002/ehf2.13257. Epub 2021 Feb 9.

  PMID: 33559346 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Biochemistry (urea, serum creatinine, eGFR, cystatin C, uric acid, sodium, potassium, calcium, phosphate, lipid levels, total protein, SGOT, SGPT, AP, ɣ-GT) * Hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count) * Fasting blood glucose, HbA1c * NT-proBNP * TSH * Spot-urine (urinary creatinine and albumin, urinary sodium and potassium) * Urinary dip stick analysis

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Clinical Research Center

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 14, 2018
• Study Start: November 30, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

DE (2)